Verastem’s Copiktra Gets Early Approval To Challenge Zydelig, Venclexta In Third-Line CLL

Copiktra (duvelisib) becomes the first dual inhibitor of PI3K delta and gamma to hit the market, placing it in competition with Gilead’s Zydelig and AbbVie’s Venclexta.

Cancer cells on scientific background.3d illustration

Verastem Inc.’s persistence has paid off as it brings Copiktra (duvelisib) to market in third-line chronic lymphocytic lymphoma (CLL) and two similar indications, roughly a couple years after Infinity Pharmaceuticals Inc. and its former partner AbbVie Inc. soured on the PI3K inhibitor’s prospects due to successful but uninspiring Phase II data in indolent non-Hodgkin lymphoma.

The US FDA okayed Copiktra on Sept. 24 – a couple weeks before its scheduled Oct. 5 action date – for treatment of relapsed/refractory CLL or small lymphocytic lymphoma (SLL), as well as granting accelerated approval for relapsed/refractory follicular lymphoma (FL) in the third-line setting

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