US clears Verastem’s Copiktra for blood cancers

The drug is an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first approved dual inhibitor of PI3K-delta and PI3K-gamma.

The US Food and Drug Administration also granted Copiktra (duvelisib) accelerated approval for the treatment of adults with relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies.

The indication in FL is approved under accelerated approval based on overall response rate, and continued clearance for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

"Copiktra is an important addition to the evolving treatment paradigm for patients with CLL/SLL and FL," said Ian Flinn, director of the Lymphoma Research Program at Sarah Cannon Research Institute and lead investigator of the DYNAMO and DUO studies.

"Copiktra is a significant addition to physicians’ treatment armamentarium that I believe will address an unmet need for patients who have limited options once they have progressed after two prior therapies."

The drug comes with a boxed warning for four fatal and/or serious toxicities: infections, diarrhea or colitis, cutaneous reactions, and pneumonitis. As such, the firm is implementing an informational Risk Evaluation and Mitigation Strategy to provide appropriate dosing and safety information to better support physicians in managing patients.

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