Actelion is granted marketing authorization by the European Commission for Ledaga (chlormethine gel) for the treatment of MF-CTCL - Seite 2

Actelion is working diligently to launch Ledaga in the EU as rapidly as possible. Actelion has agreed to a list of post-approval measures with the CHMP (Committee for Medical Products for Human Use, the scientific committee of the European Medicines Agency). Subject to fulfilling the agreed commitments and achieving market access in various countries, a potential first European launch of Ledaga is not expected before January 2018.

 

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Notes to Editor:

ABOUT LEDAGA  (CHLORMETHINE)

Ledaga (chlormethine) is an alkylating drug indicated for the treatment of mycosis fungoides-type cutaneous T-Cell lymphoma (MF-CTCL) formulated as a topical, once-daily, colorless gel.

Chlormethine gel, under the brand name Valchlor® (mechlorethamine) is commercially available in the US (since 2013) and in Israel through special import authorization procedure (since 2016). In France, patients benefit from the drug under a temporary authorization for use ("ATU") program initiated during the second half of 2014.

ABOUT MF-CTCL

Mycosis fungoides-type cutaneous T-Cell lymphoma (MF-CTCL) is a rare, but serious and life-threatening, immune system cancer that appears in the skin. MF-CTCL is the most common form of cutaneous T-cell lymphoma.

MF-CTLC typically appears in patients over 50 years of age (median age is 54), and is more common in men. It presents first as dry skin and a red rash, with or without itching. As a result, MF-CTLC is often mistaken for eczema or psoriasis, delaying diagnosis. MF-CTLC goes on to form scaly plaques on the skin, which can cover small or large areas of the skin. Large bumps or tumor nodules may also develop, and lymph nodes may be involved.

While MF-CTCL is a chronic and usually slowly progressing disease, the course of disease in individual patients is unpredictable, with some patient progressing into advanced stages. In about 34% of cases, a progression of the disease is observed, and in the most advanced stages, MF-CTCL cells can metastasize to other body tissues, including the liver, spleen and lungs.

Current research suggests that patients who are diagnosed in early stages of MF-CTCL have a normal life expectancy, however, the average time to diagnosis ranges from two to seven years. An important therapeutic objective in treating MF-CTLC is prevention of disease progression. Failure to maintain MF-CTLC in its early stages results in a drastically reduced median survival.