Chlormethine 160 mcg/g gel in mycosis fungoides-type cutaneous T-cell lymphoma: a profile of its use in the EU

Abstract

Topical chlormethine 160 mcg/g gel (Ledaga™), an alkylating chemotherapy agent, is indicated for the treatment of adult patients with mycosis-fungoides cutaneous T-cell lymphoma (MF-CTCL), with chlormethine amongst the most commonly used skin-directed treatments in early stage MF-CTCL. In the pivotal, 12-month, noninferiority trial in patients with MF-CTCL who had received ≥1 prior skin-directed therapy, topical chlormethine 160 mcg/g gel was noninferior to chlormethine 160 mcg/g ointment at study end with regard to the Composite Assessment of Index Lesion Severity (CAILS) confirmed overall response rate in primary intent-to-treat analyses, with superiority to the ointment demonstrated in efficacy evaluable analyses. Improvements in CAILS scores were observed as early as week 4, with overall responses maintained in at least 90% of patients during up to 10 months of follow-up. Chlormethine 160 mcg/g gel was generally well tolerated in the pivotal trial; all treatment-emergent adverse events were mild to moderate in severity and skin-related, with very few patients discontinuing treatment. Given its convenient once-daily regimen, improved stability and rapid drying on the skin surface, the recently approved gel formulation of chlormethine 160 mcg/g provides an improved formulation of chlormethine for the topical treatment of MF-CTCL in adult patients.