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FDA Approval for Romidepsin

Brand name(s): Istodax®

  • Approved for the treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy.

Full prescribing information is available, including clinical trial information, safety, dosing, drug-drug interactions, and contraindications.

On November 5, 2009, the Food and Drug Administration (FDA) granted approval to romidepsin for injection (Istodax®, made by Gloucester Pharmaceuticals Inc.) for the treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy.

The efficacy and safety of romidepsin were evaluated in two single-arm, multicenter, open-label trials. Efficacy was assessed in 167 patients with CTCL treated in the United States, Europe, and Australia. Study 1 included 96 patients who had received at least one prior systemic therapy. Study 2 included 71 patients who had received a median of two prior systemic therapies. In both trials, patients could be treated until disease progression. Overall response was evaluated according to a composite endpoint that included assessments of skin involvement, lymph node and visceral involvement, and Sézary cells.

The primary efficacy endpoint for both trials was the overall response rate (ORR), as based on investigator assessments and defined as the proportion of patients with confirmed complete response (CR) or partial response (PR). The ORRs in the two trials were similar (34 percent in Study 1 and 35 percent in Study 2), and CR rates were the same (6 percent). The median response duration was 15 months in Study 1 and 11 months in Study 2.

Safety data were available and evaluated in 185 patients with CTCL. The most common adverse reactions in Study 1 were nausea, fatigue, infections, vomiting, and anorexia. The most common adverse reactions in Study 2 were nausea, fatigue, anemia, thrombocytopenia, ECG T-wave changes, neutropenia, and lymphopenia. Serious adverse reactions reported in at least 2 percent of patients in Study 1 were infection, sepsis, and pyrexia. Serious adverse reactions reported in at least 2 percent of patients in Study 2 were infection, supraventricular arrhythmia, neutropenia, fatigue, edema, central line infection, ventricular arrhythmia, nausea, pyrexia, leukopenia, and thrombocytopenia.

The recommended dose and schedule of romidepsin is 14 mg/m2 intravenously over 4 hours on days 1, 8, and 15 of a 28-day cycle.

This summary was provided by Richard Pazdur, M.D., director of the FDA's Division of Oncology Drug Products.

The FDA is the division of the U.S. Department of Health and Human Services charged with ensuring the safety and effectiveness of new drugs and other products. (See "Learn How Drugs and Devices Get Approved.") The FDA's mission is to promote and protect the public health by helping safe and effective products to reach the market in a timely way, and monitoring products for continued safety after they are in use.

  • Updated: July 3, 2013