The European Commission (EC) has granted marketing authorisation for 160mcg of Actelion’s Ledaga (chlormethine gel) to treat mycosis fungoides-type cutaneous T-cell lymphoma (MF-CTCL).

MF-CTCL is a rare, chronic, potentially life-threatening immune system cancer that usually progresses slowly.

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Ledaga is an alkylating drug indicated for the topical treatment of MF type CTCL in adult patients.

The market authorisation was granted based on the results of the pivotal 201, a multicentre, randomised, observer-blinded, active-controlled study that was conducted in early stage MF-CTCL and involved 260 patients.

The 12-month study of Stage I and IIA MF-type CTCL patients was conducted in 13 US centres to evaluate the efficacy and safety of chlormethine gel.

“MF-CTCL is a rare, chronic, potentially life-threatening immune system cancer that usually progresses slowly.”

Approximately 77% of patients were treated for at least six months with chlormethine gel and achieved a clinical response in the composite assessment of index lesion severity (CAILS) score, while 59% of those treated with the compounded control had a clinical response.

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The adverse reactions reported with chlormethine gel in the study were dermatitis (54.7%), pruritus (20.3%), skin infections (11.7%), skin ulceration and blistering (6.3%), and skin hyperpigmentation (5.5%).

Actelion is soon planning to launch Ledaga in the EU and has also agreed to a list of post-approval measures with the Committee for Medical Products for Human Use (CHMP), the scientific committee of the European Medicines Agency.

MF-CTCL appears in the skin and is the most common form of cutaneous T-cell lymphoma. It typically appears in patients above 50 and is more common in men.

It initially presents itself as dry skin and a red rash, with or without itching.