EC grants marketing authorisation for Actelion’s Ledaga to treat MF-CTCL


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.

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.

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.