Potent Ventures Receives Conditional Approval from the Canadian Securities Exchange for the Change of Business to the Gummy Project


All the way through each conferences, AbbVie will provide 9 abstracts comparing epcoritamab (DuoBody®-CD3xCD20), an investigational subcutaneous bispecific antibody, together with knowledge from a couple of hands of the continued segment 1b /2 EPCORE™ NHL-2 scientific trial, comparing the security and initial efficacy of epcoritamab together with standard-of-care treatments for the remedy of quite a lot of sorts of B-cell non-Hodgkin lymphoma (NHL). Moreover, knowledge can be offered from the Section 2 REFINE find out about of investigational compound navitoclax + ruxolitinib in JAK inhibitor-treatment-naïve sufferers with myelofibrosis.

At this yr’s ASCO annual assembly AbbVie can be presenting on its cast tumor analysis with knowledge from telisotuzumab vedotin (Teliso-V) in non-small cellular lung most cancers.

All the way through the EHA Congress, the five-year replace from the CLL14 trial of a blended routine of venetoclax + obinutuzumab as opposed to obinutuzumab + chlorambucil evaluating the efficacy and protection in members with untreated continual lymphocytic leukemia (CLL) can be offered.

Information about shows are as follows:

ASCO 2022 Abstracts

Summary

Presentation Main points

All Instances in CT

Ibrutinib

Number one Effects From the Double-Blind,
Placebo-Managed, Section III SHINE Find out about of
Ibrutinib in Mixture With Bendamustine-
Rituximab (BR) and R Repairs as a
First-Line Remedy for Older Sufferers (Pts)
with Mantle Cellular Lymphoma (MCL)

Consultation: Hematologic Malignancies—
Lymphoma and Continual Lymphocytic
Leukemia

Friday, June 3, 2022

1:00 – 4:00 p.m. CT

Oral

Fastened-Period (FD) Ibrutinib (I) Plus
Venetoclax (V) for First-Line (1L) Remedy
(tx) of Continual Lymphocytic Leukemia
(CLL)/Small Lymphocytic Lymphoma (SLL)

3-year Observe-up From the FD Cohort of the
Section 2 CAPTIVATE Find out about

Consultation: Hematologic Malignancies—
Lymphoma and Continual Lymphocytic
Leukemia

Saturday, June 4, 2022

8:00 – 11:00 a.m. CT

Poster

Section 1/2 Find out about of Zilovertamab and Ibrutinib
in Mantle Cellular Lymphoma (MCL) or Continual
Lymphocytic Leukemia (CLL)

Consultation: Hematologic Malignancies—
Lymphoma and Continual Lymphocytic
Leukemia

Saturday, June 4, 2022

3:00 – 4:30 p.m. CT

Poster

Prognostic Checking out and Remedy Patterns in
Black Sufferers (Pts) With Continual
Lymphocytic Leukemia (CLL) From the
Tell CLL Potential

Observational Registry

Summary E-newsletter Most effective

Higher Gastrointestinal (GI) Morbidity, Peptic
Ulcer Possibility, and Proton Pump Inhibitor
(PPI)/H2 Blocker (H2B) Use in Sufferers (Pts)
Handled With Bruton’s Tyrosine Kinase
Inhibitors (BTKis) All the way through Regimen Care

Summary E-newsletter Most effective

Traits and Medical Results
Amongst Sufferers Receiving Both Ibrutinib or
Anti-CD20 Monotherapy as First-Line (1L)
Remedy for Continual Lymphocytic Leukemia
(CLL) / Small Lymphocytic Lymphoma (SLL)

A Retrospective Research in Group
Oncology Apply

Summary E-newsletter Most effective

Actual-Global Medical Results in Sufferers
Receiving Both Ibrutinib or Chemo-
Immunotherapy (CIT) as First-Line (1L)
Remedy for Continual Lymphocytic Leukemia
(CLL) / Small Lymphocytic Lymphoma (SLL)

A Retrospective Research

Summary E-newsletter Most effective

Venetoclax

Efficacy and Protection of Venetoclax
in Mixture With Azacitidine or Decitabine in
an Outpatient Surroundings in Sufferers with
Untreated Acute Myeloid Leukemia

Consultation: Hematologic Malignancies—
Leukemia, Myelodysplastic Syndromes, and
Allotransplant

Saturday, June 4, 2022

8:00 – 11:00 a.m. CT

Poster

Epcoritamab*

First-Line Remedy (Tx) With Subcutaneous
(SC) Epcoritamab (Epco) + R-CHOP in
Sufferers (Pts) With Prime-Possibility Diffuse Massive
B-Cellular Lymphoma (DLBCL):
Section 1/2 Knowledge
Replace

Consultation: Hematologic Malignancies—
Lymphoma and Continual Lymphocytic
Leukemia

Saturday, June 4, 2022

8:00 – 11:00 a.m. CT

Poster

Subcutaneous Epcoritamab With Rituximab +
Lenalidomide (R 2 ) in Sufferers (Pts) with
Relapsed or Refractory (R/R) Follicular
Lymphoma (FL): Replace from Section 1/2 Trial

Consultation: Hematologic Malignancies—
Lymphoma and Continual Lymphocytic
Leukemia

Saturday, June 4, 2022

8:00 – 11:00 a.m. CT

Poster

Subcutaneous Epcoritamab + R-DHAX/C in
Sufferers (Pts) With Relapsed or Refractory
(R/R) Diffuse Massive B-Cellular Lymphoma
(DLBCL) Who Are Eligible for Autologous
Stem Cellular Transplant (ASCT):
Initial
Section 1/2 Effects

Consultation: Hematologic Malignancies—
Lymphoma and Continual Lymphocytic
Leukemia

Saturday, June 4, 2022

8:00 – 11:00 a.m. CT

Poster

Epcoritamab (Epco) with Gemcitabine +
Oxaliplatin (GemOx) in Sufferers (Pts) With
Relapsed or Refractory (R/R) Diffuse Massive
B‑Cellular Lymphoma (DLBCL) Ineligible for
Autologous Stem Cellular Transplant (ASCT)
Induces Prime Reaction Price Even in Pts
Failing CAR T Remedy

Consultation: Hematologic Malignancies—
Lymphoma and Continual Lymphocytic
Leukemia

Saturday, June 4, 2022

8:00 – 11:00 a.m. CT

Poster

Navitoclax

Navitoclax Plus Ruxolitinib in JAK inhibitor-
Naïve Sufferers (Pts) With Myelofibrosis:
Initial Protection and Efficacy in a
Multicenter, Open-Label Section 2 Find out about

Consultation: Hematologic Malignancies –
Leukemia, Myelodysplastic Syndromes, and
Allotransplant

8:00 – 11:00 a.m. CT

Poster

Saturday, June 4, 2022

1:15 – 2:45 p.m. CT

Poster Dialogue

Lemzoparlimab

Lemzoparlimab (Lemzo) with Venetoclax
(Ven) and/or Azacitidine (Aza) in Sufferers
(Pts) With Acute Myeloid Leukemia (AML) or
Myelodysplastic Syndromes (MDS)

A Section 1b Dose Escalation Find out about

Consultation: Hematologic Malignancies—
Leukemia, Myelodysplastic Syndromes, and
Allotransplant

Saturday, June 4, 2022

8:00 – 11:00 a.m. CT

Poster

Teliso-V

Section 1/1B find out about of Telisotuzumab Vedotin
(Teliso-V) + Osimertinib (Osi), After Failure
on Prior Osi, in Sufferers (Pts) With Complex,
c-Met Overexpressing, EGFR-Mutated Non-
Small Cellular Lung Most cancers (NSCLC).

Consultation: Lung Most cancers – Non-Small Cellular
Metastatic

Monday, June 6, 2022

8:00 – 11:00 a.m. CT

Poster

1:15 – 2:45 p.m. CT

Poster Dialogue

Telisotuzumab Vedotin (Teliso-V)
Monotherapy in Sufferers (Pts) With
In the past Handled c-Met-Overexpressing
(OE) Complex Non-Small Cellular Lung Most cancers
(NSCLC)

Consultation: Lung Most cancers – Non-Small Cellular
Metastatic

Monday, June 6, 2022

8:00 – 11:00 a.m. CT

Poster

1:15 – 2:45 p.m. CT

Poster Dialogue

The ASCO 2022 Annual Assembly abstracts are to be had right here .

EHA 2022 Abstracts

Summary

Presentation Main points

All Instances in CT

Ibrutinib

Immune Recovery and Synergistic Job
with First-Line (1L) Ibrutinib (IBR) Plus
Venetoclax (VEN): Translational Analyses of
CAPTIVATE Trial Sufferers with CLL

Consultation: CLL: Translational Analysis

Saturday, June 11, 2022

9:30 – 10:45 a.m. CT

Oral

Number one Effects From the Section 3 Shine Find out about
of Ibrutinub in Mixture With
Bendamustine-Rituximab (BR) and R
Repairs as a First-Line Remedy for
Older Sufferers With Mantle-Cellular Lymphoma

Consultation: Indolent and Mantle Cellular Lymphoma

Saturday, June 11, 2022

4:30 – 5:45 a.m. CT

Oral

Absence of BTK, BCL2, and PLCG2 Mutations
in Relapsing Continual Lymphocytic Leukemia
(CLL) After First-Line Remedy with Fastened-
Period Ibrutinib (I) Plus Venetoclax (V)

Consultation: Continual lymphocytic leukemia and
similar problems – Medical
Friday, June 10, 2022

9:30-10:45 a.m. CT

Poster

Fastened-Period (FD) Ibrutinib + Venetoclax for
First-Line Remedy of Continual Lymphocytic
Leukemia (CLL)/Small Lymophocytic
Lymphoma (SLL): 3-12 months Observe-up From the
Section 2 CAPTIVATE Find out about FD Cohort

Friday, June 10, 2022

9:30 – 10:45 a.m. CT

Poster

Pass-Trial Research of Fastened-Period Ibrutinib
(I) Plus Venetoclax (V) Vs Fludarabine (F),
Cyclophosphamide (C), And Rituximab (R) As
First-Line Remedy for Continual Lymphocytic
Leukemia (CLL)

Consultation: Continual lymphocytic leukemia and
similar problems – Medical
Summary E-newsletter Most effective

Venetoclax***

Venetoclax-Obinutuzumab for In the past
Untreated Continual Lymphocytic Leukemia: 5-
12 months Result of the Randomized CLL14 Find out about

Consultation: CLL: Medical

Sunday, June 12, 2022

4:30 – 5:45 a.m. CT

Oral

VIALE-M: A Randomized, Double-Blind, 2-Arm,
Multicenter, Section 3 Find out about of Venetoclax and
Oral Azacitidine As opposed to Oral Azacitidine as
Repairs Remedy for Sufferers With Acute
Myeloid Leukemia in First Remission After
Extensive Chemotherapy

Consultation: Acute myeloid leukemia – Medical
Friday, June 10, 2022

9:30 – 10:45 a.m. CT

Poster

VIALE-T: A Randomized, Open-Label, Section 3
Find out about of Venetoclax in Mixture With
Azacitidine After Allogeneic Stem Cellular
Transplantation in Sufferers With Acute Myeloid
Leukemia

Consultation: Acute myeloid leukemia – Medical
Friday, June 10, 2022

9:30 – 10:45 a.m. CT

Poster

The Have an effect on of Submit-Remission Granulocyte
Colony-Stimulating Issue Use within the Section 3
Research of Venetoclax Mixture Therapies
in Sufferers With Newly Recognized Acute
Myeloid Leukemia

Consultation: Acute myeloid leukemia – Medical
Friday, June 10, 2022

9:30 – 10:45 a.m. CT

Poster

Transfusion Independence Amongst Newly
Recognized Acute Myeloid Leukemia Sufferers
Receiving Venetoclax-Primarily based Mixtures Vs
Different Treatments: Effects from the AML Actual
Global Proof (ARC) Initiative

Consultation: Acute myeloid leukemia – Medical
Friday, June 10, 2022

9:30 – 10:45 a.m. CT

Poster

Medical Results in Sufferers With
Upper-Possibility Myelodysplastic Syndromes
Receiving Hypomethylating Brokers:
a Massive Inhabitants-Primarily based Research

Consultation: Myelodysplastic syndromes – Medical
Friday, June 10, 2022

9:30 – 10:45 a.m. CT

Poster

Venetoclax in Sufferers With Continual
Lymphocytic Leukemia With 17p Deletion: 6-
12 months Observe-Up and Genomic Analyses in a
Pivotal Section 2 Trial

Consultation: CLL: Medical

Friday, June 12, 2022

4:30 – 5:45 a.m. CT

Oral

Remedy Sequences and Results of
Sufferers (Pts) with CLL Handled With Focused
Brokers in Actual-Global Settings

Consultation: Continual lymphocytic leukemia and
similar problems – Medical
Friday, June 10, 2022

9:30 – 10:45 a.m. CT

Poster

Healthcare Useful resource Usage and Prices Of
Remedy With Fastened-Period Venetoclax
Amongst CLL Sufferers (Pts)

Summary E-newsletter Most effective

Transcriptomic Characterization of MRD
Reaction and Non-Reaction in Sufferers (Pts)

Handled With Fastened-Period Venetoclax-
Obinutuzumab

Consultation: CLL: Translational

Saturday, June 11, 2022

9:30 – 10:45 a.m. CT

Oral

Fastened-Period (FD) Ibrutinib (I) Plus
Venetoclax (V) for First-Line (1L) Remedy
(Tx) of Continual Lymphocytic Leukemia (CLL) /
Small Lymphocytic Lymphoma (SLL): 3-12 months
Observe-Up From the FD Cohort of the Section 2
CAPTIVATE Find out about

Friday, June 10, 2022

9:30 – 10:45 a.m. CT

Poster

PedAL/EuPAL Global Collaboration to
Reinforce the End result of Youngsters With
Relapsed or Refractory Acute Myeloid
Leukemia (AML)

Consultation: Acute myeloid leukemia – Medical
Friday, June 10, 2022

9:30 – 10:45 a.m. CT

Poster

Pass-Trial Research of Fastened-Period Ibrutinib
(I) Plus Venetoclax (V) As opposed to Fludarabine (F),
Cyclophosphamide (C), and Rituximab (R) as
First-Line Remedy for Chromic Lymphoma
Leukemia (CLL)

Consultation: Continual lymphocytic leukemia and
similar problems – Medical
Summary E-newsletter Most effective

Protection and Effectiveness of Venetoclax
Monotherapy in Relapsed/Refractory CLL
Sufferers (Pts) With or With out Possibility-Related
Genetic Markers – Knowledge from the Observational
VeRVe Find out about

Consultation: Continual lymphocytic leukemia and
similar problems – Medical
Friday, June 10, 2022

9:30 – 10:45 a.m. CT

Poster

Effectiveness and Protection of Venetoclax in
Mixture with Rituximab (VenR) in
Relapsed/Refractory CLL Sufferers With or
With out Possibility-Related Genetic Markers –
Knowledge from the Observational VeRVe Find out about

Consultation: Continual lymphocytic leukemia and
similar problems – Medical
Friday, June 10, 2022

9:30 – 10:45 a.m. CT

Poster

Actual-Existence Efficacy and Protection of Venetoclax
Monotherapy in Relapsed/Refractory Continual
Lymphocytic Leukemia – Intervening time Research of
Multicentric Find out about VERONE

Consultation: Continual lymphocytic leukemia and
similar problems – Medical
Friday, June 10, 2022

9:30 – 10:45 a.m. CT

Poster

Venetoclax in Mixture With Obinutuzumab
in First Line Chromic Leukemia in Argentina: A
Value-Effectiveness Research

Consultation: High quality of lifestyles, palliative care, ethics
and well being economics
Friday, June 10, 2022

9:30 – 10:45 a.m. CT

Poster

Lemzoparlimab**

Lemzoparlimab (Lemzo) With Venetoclax (Ven)
And/Or Azacitidine (Aza) in Sufferers (Pts) With
Acute Myeloid Leukemia (AML) or
Myelodysplastic Syndromes (MDS): A Section
1b Dose Escalation Find out about

Consultation: Acute myeloid leukemia – Medical
Friday, June 10, 2022

9:30 – 10:45 a.m. CT

Poster

Epcoritamab*

Assessing Protection, Tolerability, and Efficacy of
Subcutaneous Epcoritamab in Novel
Mixtures With Anti-Neoplastic Brokers in
Sufferers (Pts) With Non-Hodgkin Lymphoma in
an Open-Label Section 1B/2 Find out about

Consultation: Competitive Non-Hodgkin lymphoma
– Medical
Summary E-newsletter Most effective

Subcutaneous (SC) Epcoritamab + R-CHOP in
In the past Untreated Sufferers (Pts) With Prime-
Possibility Diffuse Massive B-Cellular Lymphoma (DLBCL):
Section 1/2 Knowledge Replace

Friday, June 10, 2022

9:30 – 10:45 a.m. CT

Poster

Subcutaneous (SC) Epcoritamab With
Rituximab + Lenalidomide (R2) in Sufferers
(Pts) With Relapsed or Refractory (R/R)
Follicular Lymphoma (FL): Replace From Section
1/2 Trial

Friday, June 10, 2022

4:30 – 5:45 p.m. CT

Poster

Subcutaneous (SC) Epcoritamab + R-DHAX/C
in Sufferers (Pts) With Relapsed or Refractory
(R/R) Diffuse Massive B-Cellular Lymphoma (DLBCL)
Who Are Eligible For Autologous Stem Cellular
Transplant (ASCT): Initial Section 1/2 Knowledge

Friday, June 10, 2022

9:30 – 10:45 a.m. CT

Poster

Epcoritamab With Gemcitabine + Oxaliplatin
(GemOx) in Sufferers (Pts) With Relapsed or
Refractory (R/R) Diffuse Massive B Cellular
Lymphoma (DLBCL) Who Are Ineligible for
Autologous Stem Cellular Transplant (ASCT):
Section 1/2 Knowledge

Friday, June 10, 2022

9:30 – 10:45 a.m. CT

Poster

Navitoclax

Navitoclax Monotherapy in Sufferers (Pts) With
MF In the past Handled With JAK-2 Inhibitors:
Protection and Tolerability

Consultation: Myeloproliferative neoplasms – Medical
Friday, June 10, 2022

9:30 – 10:45 a.m. CT

Poster

Navitoclax plus ruxolitinib in JAK Inhibitor-naïve
Sufferers with Myelofibrosis: Initial Protection
and Efficacy in a Multicenter, Open-label Section
2 Find out about

Consultation: Therapies and headaches in MPN
Friday, June 11, 2022

4:30 – 5:45 a.m. CT

Oral

The EHA 2022 Congress abstracts are to be had right here .

* Epcoritamab is being co-developed via AbbVie and Genmab as a part of the firms’ wide oncology collaboration.

**Lemzoparlimab is investigational and being advanced via a complete scientific construction plan for hematologic malignancies and cast tumor in collaboration with AbbVie and I-Mab.

***Use of venetoclax in myelodysplastic syndromes (MDS) isn’t licensed and its protection and efficacy have now not been evaluated via regulatory government.

About Ibrutinib (IMBRUVICA ® )
IMBRUVICA ® (ibrutinib) is a once-daily oral drugs this is collectively advanced and commercialized via Pharmacyclics LLC, an AbbVie Corporate and Janssen Biotech, Inc. IMBRUVICA ® blocks the Bruton’s tyrosine kinase (BTK) protein, which is wanted via commonplace and ordinary B cells, to multiply and unfold. 1,2 Via blockading BTK, IMBRUVICA might lend a hand transfer ordinary B cells out in their nourishing environments within the lymph nodes, bone marrow, and different organs. 3

IMBRUVICA ® is licensed in additional than 100 international locations and has been used to regard greater than 250,000 sufferers international. There are greater than 50 company-sponsored scientific trials, together with 18 ongoing or finished Section 3 research, over 11 years comparing the efficacy and protection of IMBRUVICA ® .

IMBRUVICA ® was once first licensed via the U.S. Meals and Drug Management (FDA) in November 2013, and as of late is indicated for grownup sufferers in six illness spaces, together with 5 hematologic cancers. Those come with adults with CLL/small lymphocytic lymphoma (SLL) without or with 17p deletion (del17p) and adults with Waldenström’s macroglobulinemia (WM), in addition to grownup sufferers with prior to now handled mantle cellular lymphoma (MCL)*, grownup sufferers with prior to now handled marginal zone lymphoma (MZL) who require systemic treatment and feature gained no less than one prior anti-CD20-based treatment*, in addition to grownup sufferers with prior to now handled continual graft-versus-host illness (cGVHD) after failure of a number of strains of systemic treatment. 4

*Speeded up approval was once granted for MCL and MZL in accordance with general reaction fee. Endured popularity of MCL and MZL is also contingent upon verification and outline of scientific receive advantages in confirmatory trials.

Since 2019, the Nationwide Complete Most cancers Community ® (NCCN ® ), recommends ibrutinib (IMBRUVICA ® ) as a most popular routine for first-line remedy of CLL/SLL, with Class 1 standing for prior to now untreated sufferers with out del17p. Moreover, IMBRUVICA ® is a most popular remedy routine for prior to now untreated sufferers with del17p. Since January 2020, the NCCN Pointers suggest IMBRUVICA ® as a class 2A most popular routine for the remedy of relapsed/refractory MCL. Since September 2020, the NCCN Pointers suggest IMBRUVICA ® without or with rituximab as a Class 1 most popular routine for each untreated and prior to now handled WM sufferers.

For more info, talk over with www.IMBRUVICA.com .

*Speeded up approval was once granted for the MCL and MZL indications in accordance with general reaction fee. Endured popularity of MCL and MZL is also contingent upon verification and outline of scientific receive advantages in confirmatory trials.

Necessary Aspect Impact Knowledge 5
Sooner than taking IMBRUVICA ® , inform your healthcare supplier about all your scientific prerequisites, together with in case you:

  • have had contemporary surgical treatment or plan to have surgical treatment. Your healthcare supplier might prevent IMBRUVICA ® for any deliberate scientific, surgical, or dental process.
  • have bleeding issues.
  • have or had middle rhythm issues, smoke, or have a scientific situation that will increase your chance of middle illness, akin to hypertension, prime ldl cholesterol, or diabetes.
  • have an an infection.
  • have liver issues.
  • are pregnant or plan to turn into pregnant. IMBRUVICA ® can hurt your unborn child. If you’ll be able to turn into pregnant, your healthcare supplier will do a being pregnant check earlier than beginning remedy with IMBRUVICA ® . Inform your healthcare supplier if you’re pregnant or assume you can be pregnant throughout remedy with IMBRUVICA ® .
    • Ladies who’re in a position to turn into pregnant must use efficient start keep an eye on (birth control) throughout remedy with IMBRUVICA ® and for 1 month after the final dose.
    • Men with feminine companions who’re in a position to turn into pregnant must use efficient start keep an eye on, akin to condoms, throughout remedy with IMBRUVICA ® and for 1 month after the final dose.
  • are breastfeeding or plan to breastfeed. Don’t breastfeed throughout remedy with IMBRUVICA ® and for 1 week after the final dose.

Inform your healthcare supplier about the entire medications you are taking, together with prescription and over the counter medications, nutrients, and natural dietary supplements. Taking IMBRUVICA ® with sure different medications might impact how IMBRUVICA ® works and will purpose negative effects.

How must I take IMBRUVICA ® ?

  • Take IMBRUVICA ® precisely as your healthcare supplier tells you to take it.
  • Take IMBRUVICA ® 1 time an afternoon.
  • Swallow IMBRUVICA ® tablets or drugs entire with a tumbler of water.
  • Don’t open, spoil or bite IMBRUVICA ® tablets.
  • Don’t lower, weigh down or bite IMBRUVICA ® drugs.
  • Take IMBRUVICA ® at about the similar time every day.
  • Should you omit a dose of IMBRUVICA ® take it once you consider at the identical day. Take your subsequent dose of IMBRUVICA ® at your common time on day after today. Don’t take additional doses of IMBRUVICA ® to make up for a ignored dose.
  • If you are taking an excessive amount of IMBRUVICA ® name your healthcare supplier or move to the closest sanatorium emergency room straight away.

What must I steer clear of whilst taking IMBRUVICA ® ?

  • You must now not drink grapefruit juice, devour grapefruit, or devour Seville oranges (continuously utilized in marmalades) throughout remedy with IMBRUVICA ® . Those merchandise might build up the volume of IMBRUVICA ® to your blood.

What are the imaginable negative effects of IMBRUVICA ® ?
IMBRUVICA ® might purpose severe negative effects, together with:

  • Bleeding issues (hemorrhage) are not unusual throughout remedy with IMBRUVICA ® , and can be severe and might result in loss of life. Your chance of bleeding might build up if you’re additionally taking a blood thinner drugs. Inform your healthcare supplier in case you have any indicators of bleeding, together with: blood to your stools or black stools (looks as if tar), red or brown urine, sudden bleeding, or bleeding this is critical or that you can not keep an eye on, vomit blood or vomit looks as if espresso grounds, cough up blood or blood clots, higher bruising, dizziness, weak spot, confusion, alternate to your speech, or a headache that lasts a very long time or critical headache.
  • Infections can occur throughout remedy with IMBRUVICA ® . Those infections may also be severe and might result in loss of life. Inform your healthcare supplier straight away in case you have fever, chills, weak spot, confusion, or different indicators or signs of an an infection throughout remedy with IMBRUVICA ® .
  • Lower in blood cellular counts. Reduced blood counts (white blood cells, platelets, and pink blood cells) are not unusual with IMBRUVICA ® , however can be critical. Your healthcare supplier must do per thirty days blood assessments to test your blood counts.
  • Center issues. Severe middle rhythm issues (ventricular arrhythmias, atrial traumatic inflammation, and atrial flutter), middle failure, and loss of life have came about in other folks handled with IMBRUVICA ® , particularly in individuals who have an higher chance for middle illness, have an an infection, or who’ve had middle rhythm issues previously. Inform your healthcare supplier in case you get any signs of middle issues, akin to feeling as though your middle is thrashing speedy and abnormal, lightheadedness, dizziness, shortness of breath, swelling of the toes, ankles, or legs, chest discomfort, otherwise you faint. Should you expand any of those signs, your healthcare supplier might do a check to test your middle (ECG) and might alternate your IMBRUVICA ® dose.
  • Hypertension (high blood pressure). New or worsening hypertension has came about in other folks handled with IMBRUVICA ® . Your healthcare supplier might get started you on blood power drugs or alternate present medications to regard your blood power.
  • 2d number one cancers. New cancers have came about throughout remedy with IMBRUVICA ® , together with cancers of the surface or different organs.
  • Tumor lysis syndrome (TLS). TLS is brought about via the quick breakdown of most cancers cells. TLS may cause kidney failure and the desire for dialysis remedy, ordinary middle rhythm, seizure, and every so often loss of life. Your healthcare supplier might do blood assessments to test you for TLS.

The most typical negative effects of IMBRUVICA ® in adults with B-cell malignancies (MCL, CLL/SLL, WM and MZL) come with:

  • diarrhea
  • tiredness
  • muscle and bone ache
  • rash
  • bruising

The most typical negative effects of IMBRUVICA ® in adults with cGVHD come with:

  • tiredness
  • bruising
  • diarrhea
  • mouth sores (stomatitis)
  • muscle spasms
  • nausea
  • pneumonia

Diarrhea is a not unusual aspect impact in individuals who take IMBRUVICA ® . Drink various fluids throughout remedy with IMBRUVICA ® to lend a hand scale back your chance of dropping an excessive amount of fluid (dehydration) because of diarrhea. Inform your healthcare supplier in case you have diarrhea that doesn’t move away.

Those don’t seem to be the entire imaginable negative effects of IMBRUVICA ® . Name your physician for scientific recommendation about negative effects. You could file negative effects to FDA at 1-800-FDA-1088.

Common details about the secure and efficient use of IMBRUVICA ®
Drugs are every so often prescribed for functions rather than the ones indexed in a Affected person Knowledge leaflet. Don’t use IMBRUVICA ® for a situation for which it was once now not prescribed. Don’t give IMBRUVICA ® to folks, even supposing they have got the similar signs that you’ve. It will hurt them. You’ll ask your pharmacist or healthcare supplier for details about IMBRUVICA ® this is written for well being execs.

Please click on right here for complete Prescribing Knowledge. 5

About VENCLEXTA®/VENCLYXTO® (venetoclax) 6

VENCLEXTA®/VENCLYXTO® (venetoclax) is a first-in-class drugs that selectively binds and inhibits the B-cell lymphoma-2 (BCL-2) protein. In some blood cancers, BCL-2 prevents most cancers cells from present process their herbal loss of life or self-destruction procedure, referred to as apoptosis. VENCLXEXTA/VENCLYXTO objectives the BCL-2 protein and works to lend a hand repair the method of apoptosis.

VENCLEXTA/VENCLYXTO is being advanced via AbbVie and Roche. It’s collectively commercialized via AbbVie and Genentech, a member of the Roche Crew, within the U.S. and via AbbVie out of doors of the U.S. In combination, the firms are dedicated to BCL-2 analysis and to finding out venetoclax in scientific trials throughout a number of blood cancers. Venetoclax is licensed in additional than 80 international locations, together with the U.S.

Necessary Protection Knowledge 7

What’s a very powerful knowledge I must find out about VENCLEXTA?
VENCLEXTA may cause severe negative effects, together with:
Tumor lysis syndrome (TLS). TLS is brought about via the quick breakdown of most cancers cells. TLS may cause kidney failure, the desire for dialysis remedy, and might result in loss of life. Your healthcare supplier will do assessments to test your chance of having TLS earlier than you get started taking VENCLEXTA. You’re going to obtain different medications earlier than beginning and throughout remedy with VENCLEXTA to lend a hand scale back your chance of TLS. You may additionally want to obtain intravenous (IV) fluids into your vein. Your healthcare supplier will do blood assessments to test for TLS whilst you first get started remedy and throughout remedy with VENCLEXTA. It is very important stay your appointments for blood assessments. Inform your healthcare supplier straight away in case you have any signs of TLS throughout remedy with VENCLEXTA, together with fever, chills, nausea, vomiting, confusion, shortness of breath, seizures, abnormal heartbeat, darkish or cloudy urine, abnormal tiredness, or muscle or joint ache.

Drink various water throughout remedy with VENCLEXTA to lend a hand scale back your chance of having TLS.
Drink 6 to eight glasses (about 56 oz overall) of water every day, beginning 2 days earlier than your first dose, at the day of your first dose of VENCLEXTA, and every time your dose is higher. Your healthcare supplier might lengthen, lower your dose, or prevent remedy with VENCLEXTA in case you have negative effects. When restarting VENCLEXTA after preventing for 1 week or longer, your healthcare supplier might once more test to your chance of TLS and alter your dose.

Who must now not take VENCLEXTA?
Sure medications will have to now not be taken whilst you first get started taking VENCLEXTA and whilst your dose is being slowly higher on account of the chance of higher TLS.

  • Inform your healthcare supplier about the entire medications you are taking , together with prescription and over-the counter medications, nutrients, and natural dietary supplements. VENCLEXTA and different medications might impact every different inflicting severe negative effects.
  • Don’t get started new medications throughout remedy with VENCLEXTA with out first speaking along with your healthcare supplier.

Sooner than taking VENCLEXTA, inform your healthcare supplier about all your scientific prerequisites,
together with in case you:

  • have kidney or liver issues.
  • have issues along with your frame salts or electrolytes, akin to potassium, phosphorus, or calcium.
  • have a historical past of prime uric acid ranges to your blood or gout.
  • are scheduled to obtain a vaccine. You must now not obtain a “reside vaccine” earlier than, throughout, or after remedy with VENCLEXTA, till your healthcare supplier tells you it’s ok. Should you don’t seem to be positive about the kind of immunization or vaccine, ask your healthcare supplier. Those vaccines might not be secure or would possibly not paintings as neatly throughout remedy with VENCLEXTA.
  • are pregnant or plan to turn into pregnant. VENCLEXTA might hurt your unborn child. If you’ll be able to turn into pregnant, your healthcare supplier must do a being pregnant check earlier than you get started remedy with VENCLEXTA, and you should utilize efficient start keep an eye on throughout remedy and for a minimum of 30 days after the final dose of VENCLEXTA. Should you turn into pregnant or assume you might be pregnant, inform your healthcare supplier straight away.
  • are breastfeeding or plan to breastfeed. It isn’t identified if VENCLEXTA passes into your breast milk. Don’t breastfeed throughout remedy with VENCLEXTA and for 1 week after the final dose.

What must I steer clear of whilst taking VENCLEXTA?
You must now not drink grapefruit juice or devour grapefruit, Seville oranges (continuously utilized in marmalades), or starfruit if you are taking VENCLEXTA. Those merchandise might build up the volume of VENCLEXTA to your blood.

What are the imaginable negative effects of VENCLEXTA?
VENCLEXTA may cause severe negative effects, together with:

  • Low white blood cellular counts (neutropenia). Low white blood cellular counts are not unusual with VENCLEXTA, however can be critical. Your healthcare supplier will do blood assessments to test your blood counts throughout remedy with VENCLEXTA and might pause dosing.
  • Infections. Demise and severe infections akin to pneumonia and blood an infection (sepsis) have came about throughout remedy with VENCLEXTA. Your healthcare supplier will carefully observe and deal with you straight away in case you have a fever or any indicators of an infection throughout remedy with VENCLEXTA.

Inform your healthcare supplier straight away in case you have a fever or any indicators of an an infection throughout remedy with VENCLEXTA.

The most typical negative effects of VENCLEXTA when utilized in mixture with obinutuzumab or rituximab or by myself in other folks with CLL or SLL come with low white blood cellular counts; low platelet counts; low pink blood cellular counts; diarrhea; nausea; higher breathing tract an infection; cough; muscle and joint ache; tiredness; and swelling of your hands, legs, fingers, and toes.

The most typical negative effects of VENCLEXTA together with azacitidine or decitabine or low-dose cytarabine in other folks with AML come with nausea; diarrhea; low platelet depend; constipation; low white blood cellular depend; fever with low white blood cellular depend; tiredness; vomiting; swelling of hands, legs, fingers, or toes; fever; an infection in lungs; shortness of breath; bleeding; low pink blood cellular depend; rash; abdomen (stomach) ache; an infection to your blood; muscle and joint ache; dizziness; cough; sore throat; and coffee blood power.

VENCLEXTA might purpose fertility issues in men. This may increasingly impact your talent to father a kid. Communicate for your healthcare supplier in case you have issues about fertility.

Those don’t seem to be the entire imaginable negative effects of VENCLEXTA. Name your physician for scientific recommendation about negative effects.

You’re inspired to file negative effects of prescription drug to the FDA. Consult with www.fda.gov/medwatch or name 1-800-FDA-1088.

If you can not manage to pay for your drugs, touch genentech-access.com/affected person/manufacturers/venclexta for help .

The entire U.S. prescribing knowledge, together with Medicine Information, for VENCLEXTA ® may also be discovered right here .

Indications and Necessary Venclyxto (venetoclax) EU Protection Knowledge 8

Indications

VENCLYXTO together with obinutuzumab is indicated for the remedy of grownup sufferers with prior to now untreated continual lymphocytic leukaemia (CLL).

VENCLYXTO together with rituximab is indicated for the remedy of grownup sufferers with CLL who’ve gained no less than one prior treatment.

VENCLYXTO monotherapy is indicated for the remedy of CLL:

  • Within the presence of 17p deletion or TP53 mutation in grownup sufferers who’re fallacious for or have failed a B-cell receptor pathway inhibitor, or
  • Within the absence of 17p deletion or TP53 mutation in grownup sufferers who’ve failed each chemoimmunotherapy and a B-cell receptor pathway inhibitor

Venclyxto together with a hypomethylating agent is indicated for the remedy of grownup sufferers with newly identified acute myeloid leukaemia (AML) who’re ineligible for in depth chemotherapy.

Contraindications

Allergic reaction to the lively substance or to any of the excipients is contraindicated.  Concomitant use of robust CYP3A inhibitors at initiation and throughout the dose-titration segment because of higher chance for tumour lysis syndrome (TLS). Concomitant use of arrangements containing St. John’s wort as Venclyxto efficacy is also diminished.

Particular Warnings & Precautions for Use

Tumour Lysis syndrome, together with deadly occasions, has happened in sufferers when handled with Venclyxto. For CLL and AML, please check with the indication-specific suggestions for prevention of TLS within the Venclyxto abstract of product function (SmPC).

Sufferers must be assessed for chance and must obtain suitable prophylaxis, tracking, and control for TLS.  The chance of TLS is a continuum in accordance with a couple of elements, together with comorbidities. Venclyxto poses a chance for TLS at initiation and throughout the dose-titration segment. Adjustments in electrolytes in line with TLS that require instructed control can happen as early as 6 to eight hours following the primary dose of Venclyxto and at every dose build up. All the way through postmarketing surveillance, TLS, together with deadly occasions, has been reported after a unmarried 20 mg dose of venetoclax.

Neutropenia (grade 3 or 4) has been reported.  Entire blood counts must be monitored all the way through the remedy duration.

In sufferers with AML, neutropenia (grade 3 or 4) is not unusual earlier than beginning remedy. The neutrophil counts can irritate with Venetoclax together with a hypomethylating agent. Neutropenia can recur with next cycles of treatment. Dose amendment and interruptions for cytopenias are depending on remission standing.

For CLL and AML, please check with the indication-specific suggestions for dose changes for toxicities within the Venclyxto SmPC.

Severe infections together with sepsis with deadly result were reported. Tracking of any indicators and signs of an infection is needed. Suspected infections must obtain instructed remedy, together with antimicrobials and dose interruption or relief as suitable.

Are living vaccines must now not be administered throughout remedy or thereafter till B-cell restoration.

Drug Interactions

In CLL and AML CYP3A inhibitors might build up Venclyxto plasma concentrations.

In CLL, at initiation and dose-titration segment, Robust CYP3A inhibitors are contraindicated because of higher chance for TLS and average CYP3A inhibitors must be have shyed away from. If average CYP3A inhibitors will have to be used, please check with the suggestions for dose changes within the Venclyxto SmPC.

In AML, please check with the AML-specific advice for dose changes for attainable interactions with CYP3A inhibitors, within the VENCLYXTO SmPC.

Keep away from concomitant use of P-gp and BCRP inhibitors at initiation and throughout the dose titration segment.

CYP3A4 inducers might lower Venclyxto plasma concentrations.  Keep away from coadministration with sturdy or average CYP3A inducers. Those brokers might lower venetoclax plasma concentrations.

Co-administration of bile acid sequestrants with VENCLYXTO isn’t really useful as this will scale back the absorption of VENCLYXTO.

Adversarial Reactions

CLL

Essentially the most repeatedly going on antagonistic reactions (≥20%) of any grade in sufferers receiving venetoclax within the mixture research with obinutuzumab or rituximab have been neutropenia, diarrhoea, and higher breathing tract an infection.  Within the monotherapy research, the most typical antagonistic reactions have been neutropenia/neutrophil depend diminished, diarrhoea, nausea, anaemia, fatigue, and higher breathing tract an infection.

Essentially the most often going on severe antagonistic reactions (≥2%) in sufferers receiving venetoclax together with obinutuzumab or rituximab have been pneumonia, sepsis, febrile neutropenia, and TLS.  Within the monotherapy research, probably the most often reported severe antagonistic reactions (≥2%) have been pneumonia and febrile neutropenia.

Discontinuations because of antagonistic reactions happened in 16% of sufferers in each mixture research (CLL14 and MURANO). Within the monotherapy research with venetoclax, 11% of sufferers discontinued because of antagonistic reactions.

Dosage discounts because of antagonistic reactions happened in 21% of sufferers handled with the mix of venetoclax and obinutuzumab within the CLL14 find out about, in 15% of sufferers handled with the mix of venetoclax and rituximab within the Murano find out about, and in 14% of sufferers handled with venetoclax within the monotherapy research. The most typical antagonistic response that resulted in dose interruptions was once neutropenia.

AML

Essentially the most repeatedly going on antagonistic reactions (>=20%) of any grade in sufferers receiving venetoclax together with azacitidine or decitabine within the VIALE-A and M14-358, respectively, have been thrombocytopenia, neutropenia, febrile neutropenia, nausea, diarrhoea, vomiting, anaemia, fatigue, pneumonia, hypokalaemia, and diminished urge for food, haemorrhage, dizziness/syncope, hypotension, headache, stomach ache, and anaemia.

Essentially the most often reported severe antagonistic reactions (≥5%) in sufferers receiving venetoclax together with azacitidine have been febrile neutropenia, pneumonia, sepsis and haemorrhage. In M14-358, probably the most often reported severe antagonistic reactions (≥5%) have been febrile neutropenia, pneumonia, bacteraemia and sepsis.

Discontinuations because of antagonistic reactions happened in 24 % of sufferers handled with venetoclax together with azacitidine within the VIALE-A find out about, and 26% of sufferers handled with venetoclax together with decitabine within the M14-358 find out about, respectively.

Dosage discounts because of antagonistic reactions happened in 2% of sufferers in VIALE-A, and in 6% of sufferers in M14-358. Venetoclax dose interruptions because of antagonistic reactions happened in 72% and 65 % of sufferers, respectively. The most typical antagonistic response that resulted in dose interruption (>10%) of Venetoclax in VIALE-A, have been febrile neutropenia, neutropenia, pneumonia, and thrombocytopenia.  The most typical antagonistic reactions that resulted in dose interruption (≥5%) of venetoclax in M14-358 have been febrile neutropenia, neutropenia/neutrophil depend diminished, pneumonia, platelet depend diminished, and white blood cellular depend diminished.

Particular Populations

Sufferers with diminished renal serve as (CrCl

For sufferers with critical (Kid-Pugh C) hepatic impairment, a dose relief of no less than 50% all the way through remedy is really useful.

Venclyxto might purpose embryo-fetal hurt when administered to a pregnant lady. Advise nursing girls to discontinue breastfeeding throughout remedy.

This isn’t an entire abstract of all protection knowledge. See Venclyxto (venetoclax) SmPC at www.ema.europa.european. Globally, prescribing knowledge varies; check with the person nation product label for entire knowledge.

About Epcoritamab
Epcoritamab is an investigational IgG1-bispecific antibody created the usage of Genmab’s proprietary DuoBody era. Genmab’s DuoBody-CD3 era is designed to direct cytotoxic T cells selectively to elicit an immune reaction against goal cellular sorts. Epcoritamab is designed to concurrently bind to CD3 on T cells and CD20 on B-cells and induces T cellular mediated killing of CD20+ cells. 9 Epcoritamab was once advanced with selective, silencing mutations that can prohibit, systemic non-specific job. 10 CD20 is expressed on B-cells and a clinically validated healing goal in lots of B-cell malignancies, together with diffuse massive B-cell lymphoma, follicular lymphoma, mantle cellular lymphoma and persistent lymphocytic leukemia. 11 ,12 Epcoritamab is being co-developed via AbbVie and Genmab as a part of the firms’ wide oncology collaboration.

About Lemzoparlimab
Lemzoparlimab is investigational and being advanced via a complete scientific construction plan for hematologic malignancies and cast tumor in collaboration with AbbVie and I-Mab.

About Navitoclax
Navitoclax is an investigational, oral BCL-XL/BCL-2 inhibitor. The BCL-2 circle of relatives of proteins are identified regulators of the apoptosis pathway. 13 Navitoclax isn’t licensed via any regulatory authority. Its protection and efficacy are underneath analysis as a part of ongoing Section 2 and registrational Section 3 research.

AbbVie is lately recruiting for 2 Section 3 trials of navitoclax (TRANSFORM-1 and TRANSFORM-2) together with ruxolitinib for the remedy of myelofibrosis that may join greater than 500 sufferers. The corporate anticipates pivotal trial readouts and regulatory submission for navitoclax in 2023.

About Telisotuzumab Vedotin
Teliso-V is an investigational antibody-drug conjugate (ADC) concentrated on c-Met, a receptor tyrosine kinase this is overexpressed in tumors together with NSCLC. Teliso-V isn’t licensed via any regulatory authority and its protection and efficacy are underneath analysis.

About AbbVie in Oncology
At AbbVie, we’re dedicated to reworking requirements of handle a couple of blood cancers whilst advancing a dynamic pipeline of investigational treatments throughout a spread of most cancers sorts. Our devoted and skilled staff joins forces with cutting edge companions to boost up the supply of doubtless step forward medications. We’re comparing greater than 20 investigational medications in over 300 scientific trials throughout probably the most international’s maximum popular and debilitating cancers. As we paintings to have a outstanding affect on other folks’s lives, we’re dedicated to exploring answers to lend a hand sufferers download entry to our most cancers medications. For more info, please talk over with http://www.abbvie.com/oncology .

About AbbVie
AbbVie’s venture is to find and ship cutting edge medications that resolve severe well being problems as of late and cope with the scientific demanding situations of the next day to come. We try to have a outstanding affect on other folks’s lives throughout a number of key healing spaces: immunology, oncology, neuroscience, eye care, virology, girls’s well being and gastroenterology, along with services throughout its Allergan Aesthetics portfolio. For more info about AbbVie, please talk over with us at www.abbvie.com . Observe @abbvie on Twitter , Fb , Instagram , YouTube and LinkedIn .

Ahead-Having a look Statements
Some statements on this information liberate are, or is also thought to be, forward-looking statements for functions of the Non-public Securities Litigation Reform Act of 1995. The phrases “imagine,” “be expecting,” “await,” “undertaking” and identical expressions, amongst others, in most cases determine forward-looking statements. AbbVie cautions that those forward-looking statements are matter to dangers and uncertainties that can purpose exact effects to fluctuate materially from the ones indicated within the forward-looking statements. Such dangers and uncertainties come with, however don’t seem to be restricted to, failure to comprehend the anticipated advantages from AbbVie’s acquisition of Allergan % (“Allergan”), failure to promptly and successfully combine Allergan’s companies, festival from different merchandise, demanding situations to highbrow assets, difficulties inherent within the analysis and construction procedure, antagonistic litigation or govt motion, adjustments to regulations and laws appropriate to our trade and the affect of public well being outbreaks, epidemics or pandemics, akin to COVID-19. Further details about the industrial, aggressive, governmental, technological and different elements that can impact AbbVie’s operations is about forth in Merchandise 1A, “Possibility Elements,” of AbbVie’s 2021 Annual File on Shape 10-Ok, which has been filed with the Securities and Change Fee, as up to date via its next Quarterly Experiences on Shape 10-Q. AbbVie undertakes no legal responsibility to liberate publicly any revisions to forward-looking statements because of next occasions or trends, excluding as required via legislation.

1 Genetics House Reference. Remoted progress hormone deficiency. http://ghr.nlm.nih.gov/situation/isolated-growth-hormone-deficiency . Accessed November 2020 .
2 Turetsky, et al. Unmarried cellular imaging of Bruton’s Tyrosine Kinase the usage of an irreversible inhibitor. Medical Experiences. quantity 4, Article quantity: 4782 (2014)
3 de Rooij MF, Kuil A, Geest CR, et al. The clinically lively BTK inhibitor PCI-32765 objectives B-cell receptor- and chemokine-controlled adhesion and migration in continual lymphocytic leukemia. Blood. 2012;119(11):2590-2594.
4 IMBRUVICA U.S. Prescribing Knowledge, April 2020 .
5 IMBRUVICA U.S. Prescribing Knowledge, April 2020 .
6 Abstract of Product Traits for VENCLYXTO (venetoclax). Ludwigshafen, Germany: AbbVie Deutschland GmbH & Co. KG.
7 ISI verified in opposition to ISI indexed on venclexta.com 24Oct2021
8 Abstract of Product Traits for VENCLYXTO (venetoclax). Ludwigshafen, Germany: AbbVie Deutschland GmbH & Co. KG.
9 “Diffuse Massive B-Cellular Lymphoma.” Lymphoma Analysis Basis, https://www.lymphoma.org/aboutlymphoma/nhl/dlbcl/ ; date accessed: 11 February 2022 .
10 van der Horst, H.J., de Jonge, A.V., Hiemstra, I.H. et al. Epcoritamab induces potent anti-tumor job in opposition to malignant B-cells from sufferers with DLBCL, FL and MCL, regardless of prior CD20 monoclonal antibody remedy. Blood Most cancers J. 11, 38 (2021). https://doi.org/10.1038/s41408-021-00430-6
11 Rafiq, Sarwish, et al. “Comparative Overview of Clinically Applied CD20-Directed Antibodies in Continual Lymphocytic Leukemia Cells Unearths Divergent NK Cellular, Monocyte, and Macrophage Houses.” J. Immunol. ( Baltimore , Md. 1950), U.S. Nationwide Library of Medication, 15 Mar. 2013, www.ncbi.nlm.nih.gov/%/articles/PMC3631574/ .
12 Singh, Vijay, et al. “Construction of Novel Anti-Cd20 Monoclonal Antibodies and Modulation in Cd20 Ranges on Cellular Floor: Having a look to Reinforce Immunotherapy Reaction.” J Most cancers Sci Ther., U.S. Nationwide Library of Medication, Nov. 2015, www.ncbi.nlm.nih.gov/%/articles/PMC4939752/ .
13 Tsujimoto Y. (1998). Position of Bcl-2 circle of relatives proteins in apoptosis: apoptosomes or mitochondria?. Genes to cells: dedicated to molecular & cell mechanisms, 3(11), 697–707. https://doi.org/10.1046/j.1365-2443.1998.00223.x

Cision View unique content material: https://www.prnewswire.com/news-releases/abbvie-to-showcase-oncology-portfolio-and-pipeline-during-the-2022-asco-and-eha-annual-congresses-301546304.html

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