Mekinist shown EU green light
pharmafile | July 7, 2014 | News story | Sales and Marketing | CHMP, Cancer, GSK, Tafinlar, braf, mekinist, melanoma
The European Commission has given GlaxoSmithKline’s melanoma drug Mekinist the thumbs-up following a positive opinion in April from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).
Mekinist (trametinib) will be available as monotherapy in adults with unresectable or metastatic melanoma with a BRAF V600 mutation – the drug has not demonstrated clinical activity in patients who have progressed on a prior BRAF inhibitor therapy.
A MEK inhibitor, Mekinist blocks the activity of the MEK protein kinase: this is present in the MAPK pathway, which plays a part in the spread of melanoma, and some mutations in the BRAF gene can cause it to stimulate cancer cell growth and survival.
“MEK has been pursued as a therapeutic target in cancer for more than a decade, and Mekinist is the first medicine in this class to be licensed in Europe,” says Paolo Paoletti, GSK’s president of oncology.
And while GSK will be pleased with the EC’s decision, so will Novartis: Mekinist transfers to the Swiss group’s ownership next year as a multi-billion dollar deal between the companies goes through.
Novartis will have control of the whole of GSK’s cancer portfolio (whose sales were up 31% to £108 million in the first quarter of the year), while GSK takes over Novartis’ vaccines business.
The drug is also approved in combination with GSK’s own Tafinlar (dabrafenib) in the US and Australia, and as monotherapy in Canada.
The European regulator’s decision was based on the Phase III METRIC study of 322 patients with BRAF-mutant melanoma (types V600E and V600K) who were treatment-naïve, or may have received one prior chemotherapy treatment in the metastatic setting.
Mekinist treatment resulted in a statistically significant increase in progression-free survival (PFS) compared to chemotherapy, with a median PFS of 4.8 months versus 1.5 months.
Adam Hill
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