FDA approves topical treatment for cutaneous lymphoma

Ceptaris' Valchlor receives agency approval for mycosis fungoides-type CTCL

MALVERN, Pa. — The Food and Drug Administration approved a new drug made by Ceptaris Therapeutics for treating a type of lymphoma, the company said Monday.

Ceptaris announced the approval of Valchlor (mechlorethamine) gel for stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma, or CTCL, in patients who have previously received skin-directed therapy. The company said the drug was the only FDA-approved topical formulation of mechlorethamine, commonly known as nitrogen mustard. The drug, a chemotherapy agent, is applied to the skin once per day and dries in place. It was previously approved for intravenous treatment of the condition.

"This is good news for patients and the treatment community," Stanford University School of Medicine dermatology professor Youn Kim said. "We now have the confidence of an FDA-approved product backed by evidence from a well-controlled clinical trial that demonstrated clinically meaningful responses in the majority of patients with stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma who have received prior skin-directed therapy."

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