European Medicines Agency (EMA) recommends approval of Trametinib [Mekinist] for the treatment of melanoma with a BRAF V600E mutation

Last Updated on May 1, 2014 by Joseph Gut – thasso

April 30, 2014 – The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorisation for Mekinist (trametinib) for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600E mutation. Mekinist is the first cancer treatment that selectively targets the MEK protein kinase.

Melanoma is the most aggressive type of skin cancer and the leading cause of death from skin disease. In Europe, every year, doctors diagnose almost 60,000 new cases and approximately 16,000 people die from the cancer. Patients with unresectable or metastatic melanoma have a poor prognosis with an average overall survival of approximately one year for stage IIIc or IV of the disease.

For decades, chemotherapy and immunotherapy have been the mainstays of systemic therapy for unresectable and metastatic melanoma, however, the therapeutic landscape in the European Union (EU) has changed significantly in recent years with the authorisation of targeted treatments, including a monoclonal antibody (ipilimumab) that targets a molecule found on the surface of T cells and two medicines (vemurafenib and dabrafenib) that target the BRAF protein kinases with a genetic mutation at position 600. Mutations of the BRAF protein kinase have been identified in about half of patients with metastatic melanoma, with the BRAF V600E mutation found in about 80 to 90% of these. These mutations cause the cell to make an abnormal protein that promotes cancer growth. The BRAF protein activates a protein kinase known as MEK. By inhibiting the MEK protein kinase, Mekinist blocks the effect of the BRAF mutations that promote cancer growth.

In clinical trials in melanoma patients with BRAF V600 mutation, Mekinist demonstrated superior efficacy compared with chemotherapies. In addition, its benefits with regard to progression-free survival and overall survival were comparable to the results previously reported for BRAF inhibitors while the overall response rates seemed to be lower with the MEK inhibitor. Mekinist represents a new treatment option for these patients.

The CHMP opinion on Trametinib [Mekinist] will now be sent to the European Commission for adoption of a decision on an EU-wide marketing-authorisation.

Print Friendly, PDF & Email

Ph.D.; Professor in Pharmacology and Toxicology. Senior expert in theragenomic and personalized medicine and individualized drug safety. Senior expert in pharmaco- and toxicogenetics. Senior expert in human safety of drugs, chemicals, environmental pollutants, and dietary ingredients.

3 Comments on “European Medicines Agency (EMA) recommends approval of Trametinib [Mekinist] for the treatment of melanoma with a BRAF V600E mutation

  1. On 23 February 2017, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Mekinist. The marketing authorisation holder for this medicinal product is Novartis Europharm Ltd.

    The CHMP adopted a new indication as follows:

    “Non-small cell lung cancer (NSCLC)

    Trametinib in combination with dabrafenib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600 mutation.”

    For information, the full indications for Mekinist will be as follows1:

    “Melanoma

    Trametinib as monotherapy or in combination with dabrafenib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation (see sections 4.4 and 5.1).

    Trametinib monotherapy has not demonstrated clinical activity in patients who have progressed on a prior BRAF inhibitor therapy (see section 5.1).

    Non-small cell lung cancer (NSCLC)

    Trametinib in combination with dabrafenib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600 mutation.”

    Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

    See here for full documentation: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002643/smops/Positive/human_smop_001101.jsp&mid=WC0b01ac058001d127

  2. It’s hard to find your blog in google. I found it on 16 spot,
    you should build quality backlinks , it will help you to rank to google top 10.
    I know how to help you, just type in google – k2 seo tips and
    tricks

    • Thank you for your comment. We try gradually to improve the situation and are working on the SEO, and we are looking at the k2 option you mentioned. Thank you again.