Ceptaris Therapeutics has obtained FDA marketing approval for Valchlor (mechlorethamine) gel to topically treat stage IA and IB mycosis fungoides-type cutaneous T-Cell lymphoma (CTCL) patients who were exposed to skin-directed therapy earlier.
Formulated as once-daily, topical application that dries on the skin, Valchlor gel is the only FDA-approved formulation of mechlorethamine, commonly known as nitrogen mustard.
Chemotherapeutic agent mechlorethamine is previously approved for intravenous treatment of mycosis fungoides, the most common type of CTCL.
Positive results from a randomized, observer-blinded, non-inferiority pivotal trial that compared Valchlor to a pharmacy-compounded mechlorethamine preparation in patients with stage IA-IIA MF-type CTCL formed the base for the approval.
The Valchlor pivotal trial lead investigator, the Cutaneous Lymphoma Foundation board president, the Fox Chase Cancer Center dermatology former director Stuart Lessin said the use of topical mechlorethamine has been documented over several decades, but this is the first time that a product has gone through the rigorous FDA approval process.
"Not only is VALCHLOR manufactured under FDA's good manufacturing practices, but it will also be accompanied by patient support and assistance programs which are not currently available with compounded mechlorethamine," Lessin added.