Logo

AbbVie Reports FDA's Hold on All Clinical Trials Evaluating Venclexta/Venclyxto (venetoclax) for Multiple Myeloma

Share this

AbbVie Reports FDA's Hold on All Clinical Trials Evaluating Venclexta/Venclyxto (venetoclax) for Multiple Myeloma

Shots:

  • The partial clinical hold follows P-III BELLINI trial (M14-031)study results assessing Venetoclax + bortezomib + dexamethasone vs PBO + bortezomib + dexamethasone in patients with 1L+ r/r multiple myeloma due to a higher proportion of deaths in the experimental arm rather than PBO arm
  • The P-III BELLINI study results: observed death (21.1% vs 11.3%); grade 3-5 toxicity (86.5% vs. 87.5%); SAEs (48.2% vs. 50.0%); incidence of infection (79.8% vs 77.1%); incidence of pneumonia (20.7% vs 15.6%)
  • Venclexta/Venclyxto is a novel inhibitor of B-cell lymphoma-2 (BCL-2) protein- jointly developed & commercialized by Roche & Abbvie in the US and has received approval in 50 countries for chronic lymphocytic leukemia

Click here to read full press release/ article 

Ref: AbbVie | Image: AbbVie


Senior Editor

This content piece was prepared by our former Senior Editor. She had expertise in life science research and was an avid reader. For any query reach out to us at connect@pharmashots.com

Share this article on WhatsApp, LinkedIn and Twitter

Join the PharmaShots family of 12000+ subscribers

I accept the Terms and Conditions