Venclexta Success In Second VIALE Study Sets Up Potential Full Approval In AML

 
• By Joseph Haas
  
Generate a summary of this article
Listen to this article
Beta

Weeks after their first combo study with Venclexta in first-line AML failed, AbbVie and Genentech reported top-line data showing that the BCL-2 inhibitor plus azacitidine improved survival and remission rates.

Leukemia
New data may position Venclexta for full approval in acute myeloid leukemia

The second of two Phase III studies testing Venclexta (venetoclax) with a chemotherapy agent in first-line acute myeloid leukemia has hit both of its co-primary endpoints and the results will be reported early, sponsors AbbVie Inc. and Genentech Inc. said on 23 March. The data position the BCL-2 inhibitor for a full approval in first-line, transplant-ineligible AML patients after a US accelerated approval in 2018.

The companies announced that in the 433-patient VIALE-A study, Venclexta plus azacitidine achieved statistical significance compared to azacitidine and placebo...

Scrip Podcast

Keep up with the top pharma business news of the week. On the go.

Scrip brings you a weekly bulletin of top picks.

SpotifyApple PodcastsWebsite

More from Clinical Trials

  • Sciwind Eyes Differentiation For Ecnoglutide In Highly Competitive Arena

     
    • By Xu Hu

    Chinese firm Sciwind has revealed additional Phase III findings for its promising once-weekly GLP-1 agonist ecnoglutide, just one asset in a burgeoning Chinese sector that could see the emergence of new rivals to current global leaders in obesity and diabetes.

  • Fosun ALK/ROS1 Inhibitor Shows 1L Promise In Advanced NSCLC

     
    • By Xu Hu

    Interim results from the Phase III REMARK study presented at WCLC showed the Chinese company’s second-generation ALK/ROS1 inhibitor met its primary endpoint as a first-line therapy in ALK-positive advanced NSCLC.

  • Sponsored By:

    Nancy Tests SPARC-931-part

    The article discusses the impact of upcoming patent expirations in oncology biologics on biosimilar developers, highlighting the opportunities in Antibody-Drug Conjugates (ADCs) and Bispecific Antibodies (BsAbs). It explores the challenges posed by the structural complexities of these biologics, necessitating new bioanalytical tools and manufacturing processes. The evolving regulatory landscape, with contributions from EMA, FDA, and WHO, offers flexible pathways but also presents challenges. The article underscores the potential for biosimilars to generate significant cost savings and enhance patient access to cancer treatments over the next decade.

  • Fosun ALK/ROS1 Inhibitor Shows 1L Promise In Advanced NSCLC

    Interim results from the Phase III REMARK study presented at WCLC showed the Chinese company’s second-generation ALK/ROS1 inhibitor met its primary endpoint as a first-line therapy in ALK-positive advanced NSCLC.

More from R&D