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FDA grants orphan drug designation to Copiktra for T-cell lymphoma
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The FDA granted duvelisib orphan drug designation for the treatment of T-cell lymphoma, according to a press release from the drug’s manufacturer.
Duvelisib (Copiktra, Verastem) — an oral inhibitor of phosphoinositide 3-kinase, or PI3K — is currently approved for the treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma after at least two prior therapies and for follicular lymphoma after at least two prior systemic therapies.
The ongoing phase 2 PRIMO study is evaluating, efficacy, tolerability and dosing regimens of duvelisib monotherapy for patients with relapsed or refractory peripheral T-cell lymphoma.
“Receiving orphan drug designation for T-cell lymphoma, in addition to the previously granted fast track status for peripheral T-cell lymphoma, marks another important regulatory milestone to bring Copiktra to patients who are faced with this aggressive type of disease with limited therapeutic options,” Brian Stuglik, CEO of Verastem Oncology, said in a press release. “We look forward to sharing the results of our phase 2 PRIMO study and efficiently advancing our development program in this indication.”
The FDA Office of Orphan Products Development grants orphan drug designation to novel drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States. The designation allows manufacturers to qualify for various incentives, including tax credits for qualified clinical trials and — upon regulatory approval — 7 years of market exclusivity.