The FDA has approved duvelisib capsules for the treatment of adults with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) or relapsed/refractory follicular lymphoma, after at least two therapies, according to a press release.

Duvelisib (Copiktra; Verastem) is an oral capsule that inhibits the phosphoinositide 3-kinase (PI3K). According to the press release, the drug is the first approved dual inhibitor of PI3K-delta and PI3K-gamma.

Clinical trials. Pixabay.

"[Duvelisib] is an important addition to the evolving treatment paradigm for patients with CLL/SLL and FL," Ian Flinn, MD, PhD, director of the Lymphoma Research Program at Sarah Cannon Research Institute and lead investigator of the DYNAMO and DUO trials, said in the press release. "The approval of [Duvelisib] for the treatment of relapsed or refractory CLL/SLL after at least two prior therapies, or relapsed or refractory FL after at least two prior systemic therapies, is based on clinical trial data gathered from the treatment of over 400 adult patients.”

The FDA explained that because the relapsed/refractory follicular lymphoma approval is on the accelerated approval track, continued approval for this indication will be based on verification of the drug’s benefit in further confirmation trials.

Duvelisib will be available to patients immediately, the press release noted. Duvelisib previously received Fast Track Designation and Orphan Drug Designation from the FDA.

“[Duvelisib] 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," Flinn concluded.