FDA Approves Verastem’s Copiktra for Leukemia, Lymphoma

The FDA granted approval for Verastem’s Copiktra (duvelisib) for treating adult patients with refractory or relapsed chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after attempting at least two prior therapies.

Duvelisib also received accelerated approval for adult patients with relapsed or refractory follicular lymphoma (FL) after trying at least two prior systemic therapies.

The capsule comes with a boxed warning for four fatal or serious toxicities — pneumonitis, infections, cutaneous reactions and diarrhea or colitis. Verastem has implemented a REMS to give physicians appropriate dosing and safety information.