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# Orphan Drug Status for Verastem’s Copiktra
- URL: https://www.fdaweb.com/orphan-drug-status-for-verastems-copiktra/
- Published: 2019-10-03T12:00:00.000Z
- Updated: 2026-09-15T01:54:00.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145165

FDA has granted Verastem an orphan drug designation for Copiktra (duvelisib) for use in treating T-Cell lymphoma. The therapy is currently approved in the U.S. for treating chronic lymphocytic leukemia/small lymphocytic lymphoma after at least two prior therapies have failed, and accelerated approval in follicular lymphoma after at least two prior systemic therapies. The ongoing Phase 2 PRIMO study will “provide guidance on a duvelisib monotherapy dosing regimen in patients with relapsed or refractory peripheral T-cell lymphoma and further characterize its efficacy and tolerability in this population,” the company says. Peripheral T-cell lymphoma is a rare, aggressive type of non-Hodgkin lymphoma (NHL) that accounts for between 10-15% of all NHL cases and mostly affects people aged 60 years and older.