FDA approves treatment for T-cell lymphoma after strong results in clinical trial

WOODCLIFF LAKE, N.J. The Food and Drug Administration has approved a supplemental biologics license application for Eisai’s lymphoma drug Ontak, Eisai said Wednesday.

The drug, known generically as denileukin diftitox, is an injection for treating persistent or recurrent cutaneous T-cell lymphoma.

The FDA’s action was based on a phase 3 clinical trial that evaluated the safety and efficacy of Ontak in certain patients with CTCL, which refers to a group of rare, malignant lymphomas that occur primarily in the skin. Eisai said the trial was the largest randomized, double-blind and placebo-controlled phase III study ever conducted on the disease.

“These data confirm the benefit of the safety and efficacy profiles of Ontak,” Yale Cancer Center professor of medicine, Francine Foss, said.