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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