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FDA grants priority review for romidepsin for peripheral T-cell lymphoma

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The FDA has granted priority review to the supplemental New Drug Application for romidepsin injection for patients with peripheral T-cell lymphoma who have received at least one therapy.

The priority review status for romidepsin (Istodax, Celgene) came in the wake of phase 2 results presented at the December meeting of the American Society of Hematology. The trial involved 131 patients from 48 centers on three continents.

Among 17 patients who achieved complete response, 94% had not progressed by the cutoff date. Sixteen percent of patients achieved complete response plus complete responses unconfirmed, and 14% of patients experienced partial response.

The longest duration of response was more than 26 months. The average duration of follow-up was 8.2 months. Thirteen patients continue to be treated with the drug (range, 10-36 cycles).

The researchers said romidepsin may be a candidate for novel regimens in peripheral T-cell lymphoma treatment.

Coiffier B. #114. Presented at: 52nd ASH Annual Meeting; Dec. 4-7, 2010; Orlando, Fla.

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