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

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: The Business Journals