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Cautious Restart To Venetoclax’s CANOVA Trial In Multiple Myeloma

 
• By John Davis

The US FDA has lifted a partial clinical hold on one study of venetoclax in multiple myeloma, but other trials of the first-in-class agent in the potential additional indication remain on hold.  

Ground crew
CANOVA Gets The Go-Ahead • Source: Shutterstock.

The lifting of the US FDA’s partial clinical hold on only one clinical study – CANOVA – of AbbVie Inc./Roche’s bcl-2 inhibitor, Venclexta (venetoclax), in multiple myeloma, after changes to its design and while keeping the hold on other studies in multiple myeloma, suggests a cautious approach is being taken to further evaluation of the drug for the additional indication.

Concerns about a higher proportion of deaths seen in the venetoclax arm than the placebo arm of another clinical study,...

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