X
Pharma Advancement
  • Home
  • Articles
  • Drug Development
    • All
    • Clinical Trials
    • FDA Approvals
    • Research & Development
    Avadel Pharmaceuticals Receives

    Avadel Pharmaceuticals Receives Orphan Drug Designation from FDA for LUMRYZ™ (sodium oxybate) for Extended-Release Oral Suspension for the Treatment of Idiopathic Hypersomnia

    Robots and AI in Drug

    Robots and AI in Drug Discovery Are Transforming Medicine

    Stringent Policy around COVID Vaccines Laid by FDA

    Stringent Policy around COVID Vaccines Laid by FDA

    Pharmaceutical-Chemicals Market Booms with Rising API Demand

    Pharmaceutical Chemicals Market Booms with Rising API Demand

    Next in Pharma 2025 Innovations

    Next in Pharma 2025: Innovations Shaping the Future

    Work Smart: Go for Hands-Free Lab Informatics at the Bench, Not Scribbled Notes and Delayed Documentation at Your Desk

    Clinical Development

    AI Revolutionizing Drug Discovery and Clinical Development

    Drug-Development

    China’s Super Me-Too Drug Development: A New Pharma Frontier

    Omics Based Clinical Trials

    Asia Pacific Omics-Based Clinical Trials Market Growth

  • Manufacturing
  • Supply Chain
  • Facilities
  • Insights
  • Events
  • Contact Us
No Result
View All Result
  • Home
  • Articles
  • Drug Development
    • All
    • Clinical Trials
    • FDA Approvals
    • Research & Development
    Avadel Pharmaceuticals Receives

    Avadel Pharmaceuticals Receives Orphan Drug Designation from FDA for LUMRYZ™ (sodium oxybate) for Extended-Release Oral Suspension for the Treatment of Idiopathic Hypersomnia

    Robots and AI in Drug

    Robots and AI in Drug Discovery Are Transforming Medicine

    Stringent Policy around COVID Vaccines Laid by FDA

    Stringent Policy around COVID Vaccines Laid by FDA

    Pharmaceutical-Chemicals Market Booms with Rising API Demand

    Pharmaceutical Chemicals Market Booms with Rising API Demand

    Next in Pharma 2025 Innovations

    Next in Pharma 2025: Innovations Shaping the Future

    Work Smart: Go for Hands-Free Lab Informatics at the Bench, Not Scribbled Notes and Delayed Documentation at Your Desk

    Clinical Development

    AI Revolutionizing Drug Discovery and Clinical Development

    Drug-Development

    China’s Super Me-Too Drug Development: A New Pharma Frontier

    Omics Based Clinical Trials

    Asia Pacific Omics-Based Clinical Trials Market Growth

  • Manufacturing
  • Supply Chain
  • Facilities
  • Insights
  • Events
  • Contact Us
No Result
View All Result
Pharma Advancement
No Result
View All Result
Home Americas

ABBVIE ANNOUNCES SUBMISSION OF A SUPPLEMENTAL NEW DRUG APPLICATION FOR IMBRUVICA® (IBRUTINIB) FOR TREATMENT-NAIVE CHRONIC LYMPHOCYTIC LEUKEMIA

Yuvraj_pawp by Yuvraj_pawp
5th October 2015
in Americas, News

Note* - All images used are for editorial and illustrative purposes only and may not originate from the original news provider or associated company.

a global biopharmaceutical company, announced today that it submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) based on the randomized, multi- center, open-label Phase III RESONATETM-2 (PCYC-1115) trial assessing the use of IMBRUVICA® (ibrutinib) versus chlorambucil in treatment-naive chronic lymphocytic leukemia (CLL) patients aged 65 years or older. AbbVie announced top-line findings from the trial in June 2015 showing that IMBRUVICA improved progression-free survival (PFS; primary endpoint) and multiple secondary endpoints including overall survival (OS) and overall response rate (ORR) in treatment-naive patients with CLL. IMBRUVICA is jointly developed and commercialized by Pharmacyclics LLC, an AbbVie Company and Janssen Biotech, Inc.

“This submission highlights the expanded potential and strong value of IMBRUVICA as a treatment for CLL,” said Erik von Borcke, President of Pharmacyclics. “We are pleased treatment-naive patients may soon have an alternative to traditional cytotoxic chemotherapy.”

IMBRUVICA is currently approved for the treatment of patients with CLL who have received at least one prior therapy and CLL patients (including treatment-naive) who have del 17p, a genetic aberration that occurs when part of chromosome 17, the location of the tumor suppressor gene p53, has been lost or deleted.

The data have been submitted for publication in a peer-reviewed journal and presentation at an upcoming medical conference.

The RESONATE-2 trial is a Pharmacyclics-sponsored study and its protocol and specific performance goals were established in a special protocol assessment (SPA) with the FDA. A SPA is an agreement with the FDA that a Phase III clinical trial design, its clinical endpoints and statistical analyses are acceptable to the Agency to support a submission and potential approval. The trial enrolled 269 treatment-naive patients with CLL or small lymphocytic lymphoma (SLL) aged 65 years or older in the U.S., EU and other regions. Patients were randomized to receive either ibrutinib 420 mg orally, once daily until progression or unacceptable toxicity, or chlorambucil on days 1 and 15 of each 28-day cycle for up to 12 cycles. The starting dose for chlorambucil in Cycle 1 was 0.5 mg/kg and was increased based on tolerability in Cycle 2 by increments of 0.1 mg/kg to a maximum of 0.8 mg/kg. The primary endpoint of the study was PFS as assessed by an Independent Review Committee according to the International Workshop on Chronic Lymphocytic Leukemia (iWCLL) 2008 criteria, with modification for treatment-related lymphocytosis. Key secondary endpoints included ORR, OS and safety.

About Chronic Lymphocytic Leukemia (CLL)

The prevalence of CLL/SLL is approximately 115,000 patients in the United States,i with approximately 16,000 newly diagnosed patients every year.ii As this orphan disease frequently progresses following treatment with existing first-line therapies, patients are faced with fewer treatment options and often are prescribed multiple lines of therapy as they relapse or become resistant to current standard of care treatments.

In CLL/SLL, the genetic aberration del 17p occurs when part of chromosome 17, the location of the tumor suppressor gene p53, has been lost or deleted. CLL/SLL patients with del 17p have poor treatment outcomes.iv Del 17p is reported in approximately 7% of treatment-naive CLL/SLL cases,v and approximately 20% to 40% of relapsed/refractory patients harbor the mutation.

Tags: America
Previous Post

ABBVIE ANNOUNCES PLANS TO PROCEED TO PHASE 3 EVALUATION OF ELAGOLIX IN PATIENTS WITH UTERINE FIBROIDS

Next Post

Keytruda Approved for Leading Form of Lung Cancer

Related Posts

WuXi Biologics and Virogen Bio partner to advance VG712
News

WuXi Biologics and Virogen Bio partner to advance VG712

19th June 2025
Construction of WuXi Biologics Microbial Manufacturing Site
News

Construction of WuXi Biologics Microbial Manufacturing Site

19th June 2025
Beyfortus From Sanofi to Make Imprint in 2025 26 RSV Season
News

Beyfortus From Sanofi to Make Imprint in 2025-26 RSV Season

19th June 2025
Thermo-Fischer-Accelerator Drug Development an Ideal Choice
News

Thermo Fischer Accelerator Drug Development an Ideal Choice

19th June 2025
IQVIA Custom Built AI Agents for Life Sciences Healthcare
News

IQVIA Custom-Built AI Agents for Life Sciences, Healthcare

19th June 2025
SCHOTT Pharma Invests
News

SCHOTT Pharma Invests EUR 100 Million in RTU Cartridges

9th June 2025
Next Post

Keytruda Approved for Leading Form of Lung Cancer

Qucik Links

  • Drug Development
  • Manufacturing
  • News
  • Events & Conferences
  • Newsletter Archive
Pharma Advancement

About Us

Pharma Advancement is a leading Pharma information centric website. On one side Pharmaadvancement.com has established itself as one of the most efficient and comprehensive source of Pharma information online, dedicated to providing decision makers in all the Pharma industry sectors with reliable, accurate and useful insights into happenings in the Pharma sector.

Subscribe Us

System

  • Search
  • Sitemap
  • RSS Feed

Resources

  • Advertise with us
  • Contact Us
  • Download Mediapack
  • Newsletters Archive

© 2017 Copyright © Valuemediaservices 2017 All rights reserved.

No Result
View All Result
  • Home
  • Articles
  • Drug Development
  • Manufacturing
  • Supply Chain
  • Facilities
  • Insights
  • Events
  • Contact Us

© 2017 Copyright © Valuemediaservices 2017 All rights reserved.

Login to your account below

Forgotten Password?

Fill the forms bellow to register

All fields are required. Log In

Retrieve your password

Please enter your username or email address to reset your password.

Log In