Ceptaris Earns FDA Approval for Valchlor to Treat Mycosis Fungoides-type CTCL

Ceptaris Therapeutics announced today that the U.S. Food and Drug Administration has granted marketing approval for the orphan drug Valchlor (mechlorethamine) gel for the topical treatment of stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma (CTCL) in patients who have received prior skin-directed therapy. 

Mycosis fungoides is the most common type of CTCL. 

The first of its kind

Valchlor, therefore, becomes the first and only FDA-approved topical formulation of mechlorethamine (commonly known as nitrogen mustard). Valchlor is a gel applied topically once a day.

Said Youn H. Kim, M.D., Joanne and Peter Haas Jr. Professor for Cutaneous Lymphoma Research, professor of dermatology, and director of Multidisciplinary Cutaneous Lymphoma Clinic at Stanford University School of Medicine:

This is good news for patients and the treatment community. We now have the confidence of a 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.

About mechlorethamine

Mechlorethamine is a chemotherapy drug previously approved for intravenous treatment of mycosis fungoides. Prior to this approval, no FDA-approved topical mechlorethamine products were on the market. Only non-standardized, pharmacy-compounded petroleum ointment or aqueous-based topical preparations were available.

Source: Ceptaris