FDA lifts partial hold on AbbVie’s study of venetoclax in multiple myeloma

The FDA has removed the partial clinical hold on AbbVie’s (NYSE:ABBV) Phase 3 clinical trial, CANOVA, evaluating the combination of Venclexta/Venclyxto (venetoclax) and dexamethasone versus Celgene’s (NASDAQ:CELG) Pomalyst (pomalidomide) + dexamethasone in patients with relapsed/refractory multiple myeloma (MM) who are positive for the translocation [t(11;14)] abnormality, a type of MM associated with a poor prognosis.

The agency removed the partial hold, which suspended patient recruitment but allowed continued treatment for currently enrolled participants, after the company revised the protocol, including new risk mitigation measures.

The FDA suspended enrollment in March in all venetoclax trials after reviewing data from the Phase 3 BELLINI study that showed a higher rate of deaths in the treatment group compared to control.

Shares are up a fraction premarket.

https://seekingalpha.com/news/3473216-fda-lifts-partial-hold-abbvies-study-venetoclax-multiple-myeloma