Istodax Gets FDA Approval

The FDA has approved Istodax (romidepsin), an injectable medication, for treatment of patients with cutaneous T-cell lymphoma (CTCL). Istodax interferes with processes required for cell replication. It is intended to be used in patients when CTCL gets worse or comes back after at least one other type of chemotherapy has been used.

The drug was evaluated based on two clinical studies involving a total of 167 patients. About 35% of patients in both of the trials experienced tumor responses, indicating a reduction of the size of tumors. Responses lasted a median of 15 months in one study and 11 months in the other study.

The study result shows that 6% of those studied had complete responses, indicating no apparent evidence of the tumor on physical, laboratory, and X-ray examinations. Istodax is marketed by Gloucester Pharmaceuticals.

Richard Pazdur, director of the office of oncology drug products in the center for drug evaluation and research at FDA, said: “This approval demonstrates FDA’s commitment to the development and approval of drugs for rare and uncommon diseases.”