The FDA approved Actelion's Valchlor (mechlorethamine), the first and only FDA-approved topical formulation of mechlorethamine. Valchlor, a gel that is applied topically once a day, is an alkylating drug indicated to treat patients with stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma (MF-CTCL) who have received prior skin-directed therapy. Valchlor is an orphan drug that was acquired by Actelion US Holding Company, a subsidiary of Actelion Ltd., earlier this year as part of a merger with Ceptaris Therapeutics, Inc. Valchloris distributed in the US by Accredo Specialty Pharmacy.

“The availability of VALCHLOR is exciting news for patients and the treatment community. Physicians now have the option to treat appropriate MF-CTCL patients with the first formulation of topical mechlorethamine that is FDA-approved based on rigorous clinical evidence to support its use,” said Youn H. Kim, M.D., Joanne and Peter Haas Jr. professor for cutaneous lymphoma research, professor of dermatology, and director, Multidisciplinary Cutaneous Lymphoma Clinic, Stanford University School of Medicine.

“The use of topical mechlorethamine has been documented over several decades,” said Stuart Lessin, MD former director of dermatology at the Fox Chase Cancer Center, president of the Board of Directors of the Cutaneous Lymphoma Foundation, and lead investigator in the VALCHLOR pivotal trial. "With the launch of Valchlor, physicians can prescribe with confidence knowing that an FDA-approved formulation is now available, along with support and financial-assistance programs for eligible patients to help facilitate education and access."

Mycosis fungoides is the most common type of cutaneous T-cell lymphoma, a rare form of non-Hodgkin's lymphoma. In the US, approximately 20,000 patients are currently diagnosed with stage IA-IB MF-CTCL, qualifying it as a rare or orphan disease.