WASHINGTON -- The FDA has approved romidepsin (Istodax) for patients with cutaneous T-cell lymphoma who have received at least one prior systemic therapy.
Approval for the drug -- a histone deacetylase (HDAC) inhibitor -- was based on efficacy data from two multicenter, single-arm clinical studies involving 167 patients in the U.S., Europe, and Australia.
The first study included 96 patients with at least one prior systemic therapy failure. The second included 71 patients who had undergone at least two prior topical therapies or one or more systemic therapies.
Patients with stage IIB or greater disease progression made up 71% of the first study's population and 87% in the second study.
Endpoints included assessments of skin involvement, lymph node and visceral involvement, and abnormal circulating T-cells and were based on assessments of percentage of patients who had a complete (no evidence of disease) or a partial response (a 50% or greater improvement of disease), as well as duration of response and how long it to took to achieve it.
Response rates in both studies were around 35% with a complete response rate of 6%.
Median length of response was 15 months in study one and 11 months in study two, with a median time to first response of two months in both studies.
Common adverse reactions were nausea, fatigue, vomiting, neutropenia, and lymphopenia.
Additional side effects include thrombocytopenia, leukopenia, fetal harm, anorexia, and infections.
Hematological parameters should be monitored in patients taking the romidepsin and dosages modified as necessary, according to manufacturer Gloucester Pharmaceuticals.
The drug should not be given with strong or potent CYP3A4 inducers and should be administered cautiously with P-glycoprotein inhibitors.
Romidepsin may reduce the effectiveness of estrogen-containing contraceptives and should not be taken by pregnant women.
"The approval of a second HDAC inhibitor in cancer is very exciting and speaks to the potential for this class of compounds," Paul A. Bunn, Jr., MD, of the University of Colorado Cancer Center and past-president of the American Society of Clinical Oncology said in a release from romidepsin's manufacturer.