FDA allows Phase III study of venetoclax to proceed

24 June 2019

The US Food and Drug Administration has lifted the partial clinical hold placed on CANOVA (M13-494) in March this year, a Phase III trial evaluating venetoclax (trade named Venclexta and Venclyxto) for the investigational treatment of relapsed/refractory multiple myeloma.

The drug is being developed by the USA’s AbbVie (NYSE: ABBV), which made the announcement, in partnership with Swiss pharma giant Roche’s ROG: SIX) Genentech subsidiary.

However, nine other studies for Venclexta remain suspended for safety concerns.

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