FDA approves Verastem's duvelisib

FDA approved Copiktra duvelisib from Verastem Inc. (NASDAQ:VSTM) to treat relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior therapies. The agency also granted accelerated approval to the drug for relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. The approvals came ahead of the application's Oct. 5 PDUFA date.

Verastem plans to launch Copiktra in the U.S. immediately. The drug will have a monthly list price of $11,800, Chief Commercial Officer Joseph Lobacki said on a conference call Monday...