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 MM due to a higher proportion of deaths in the experimental arm vs PBO arm
  • The P-III BELLINI study results: observed death (21.1% vs 11.3%); Gr 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 BCL-2 protein, jointly developed & commercialized by Roche & AbbVie in the US and has received approval in 50 countries for CLL

CI Comments/ Implications:

  • The evaluation of venetoclax will continue to remain on a partial clinical hold while the FDA will continue to evaluate the further steps whereas the hold doesn’t affect any of the previously approved indications for venetoclax
  • AbbVie will continue working with the FDA and worldwide regulatory agencies to determine new therapies for MM program and for further R&D of venetoclax and other therapies to improve QoL in blood cancers
  • Post the hold by FDA on venetoclax in MM, AbbVie acquired TeneBio’s TNB-383B Bispecific being tested in MM in Phase I

Click here to­ read full press release/ article | Ref: AbbVie| Image: PharmaWorld

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