The FDA has granted marketing approval for Valchlor (mechlorethamine; Ceptaris) topical gel for the treatment of stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma (CTCL) in patients who have received prior skin-directed therapy. Valchlor is the first FDA-approved once daily topical formulation of mechlorethamine, commonly known as nitrogen mustard.
The approval of Valchlor was based on a randomized, observer-blinded, non-inferiority pivotal trial comparing Valchlor to a pharmacy-compounded mechlorethamine preparation in patients with stage IA-IIA MF-type CTCL.
Patients had received at least one prior skin-directed therapy of topical corticosteroids, phototherapy, Targretin gel, or topical nitrogen mustard (mechlorethamine). Patients were not required to be refractory to or intolerant of prior therapies. In the 13 center study, 260 patients (the vast majority of whom were IA and IB) were randomized 1:1, making it the largest randomized study ever conducted in mycosis fungoides-type CTCL.
In this study, 60% of patients treated with Valchlor had a confirmed response at 12 months, defined as reduction of at least 50% in the Composite Assessment of Index Lesion Severity (CAILS) score, while 48% of those treated with the compounded control achieved a confirmed response. Complete responses constituted a minority of the CAILS overall response. CAILS responses were seen as early as 1 month, with further responses observed through 11 months of treatment.
Valchlor is expected to be available through Accredo Specialty Pharmacy in the fourth quarter of 2013.
For more information call (610) 975-9290 or visit Valchlor.com.