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

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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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