EU Panel Likes Trametinib for Advanced Melanoma

Nick Mulcahy


April 25, 2014

The review panel for the European Medicines Agency (EMA) has recommended marketing authorization for trametinib (Mekinist, GlaxoSmithKline) for the treatment of adults with unresectable or metastatic melanoma with a BRAF V600 mutation.

Before using trametinib, patients must have a confirmed BRAF V600 mutation from a validated test.

The opinion on trametinib from the EMA Committee for Medicinal Products for Human Use (CHMP) will now be sent to the European Commission for a final decision on approval.

Trametinib is the first available MEK inhibitor for use in melanoma. It is already approved in the United States for use as a single agent and in combination with dabrafenib (Tafinlar, GlaxoSmithKline), which has a slightly different mechanism of action (BRAF inhibition).

However, the CHMP recently rejected the combination therapy approach, saying it wanted to see more mature data.

In clinical trials of melanoma patients with BRAF V600 mutations, trametinib was demonstrated to be more effective than chemotherapies.

Also, progression-free and overall survival results were comparable to results previously reported for the BRAF inhibitors vemurafenib (Zelboraf, Roche) and dabrafenib, both of which are already approved in Europe.

Notably, trametinib has not demonstrated clinical activity in patients who have progressed on previous BRAF inhibitor therapy.

New Indications for Sorafenib and Gardasil/Silgard

The CHMP has also issued a positive opinion for an additional indication for 2 other products related to cancer.

Sorafenib (Nexavar, Bayer) is already approved for use in the treatment of hepatocellular cancer and renal cell carcinoma (after interferon-alpha or interleukin-2 therapy). Now, the CHMP has recommended approval for another indication — thyroid cancer. Specifically, sorafenib would be indicated for use in for patients with progressive, locally advanced, or metastatic differentiated thyroid carcinoma (papillary, follicular, or Hurthle cell) that is refractory to radioactive iodine. Sorafenib is already approved in the United States for use in thyroid cancer.

In addition, a new indication has been recommended for the vaccine products Gardasil (Sanofi Pasteur MSD) and Silgard (Merck Sharp & Dohme), which offer protection against human papilomavirus types 6, 11, 16, and 18. The new indication covers the use of the vaccines for the prevention of premalignant anal lesions and anal cancers. This indication is already approved in the United States. The vaccines were already approved for use in preventing premalignant genital lesions (cervical, vulval, and vaginal) and genital warts.


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