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GSK’s Mekinist on course for EU melanoma approval

Only new medicine recommended in latest CHMP opinions
GSK GlaxoSmithKline house

GlaxoSmithKline's (GSK) skin cancer drug Mekinist was the only new medicine recommended by the European Medicines Agency (EMA) in its latest batch of opinions.

The EMA's Committee for Medicinal Products for Human Use (CHMP) gave its backing to the drug for the treatment of adult patients with advanced melanoma who have the BRAF V600 genetic mutation.

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 per cent of this group.

The CHMP recommendation comes one year after Mekinist (trametinib) was approved in the US in a similar indication and means the drug is now on course for full approval in the EU.

Once available Mekinist would offer direct competition to Roche's Zelboraf (vemurafenib), which was approved in 2012 for the treatment of advanced melanoma patients with the BRAF V600 genetic mutation.

Bristol-Myers Squibb's (BMS) Yervoy (ipilimumab) is another drug that has won EU approval for melanoma in recent years, although its recommendation covers any adult with advanced melanoma, not just those with the genetic mutation.

Mekinist differs from its competitors in that it is the first drug recommended by the EMA that selectively targets the MEK protein kinase – a protein that is activated by BRAF and can promote growth of cancer cells.

This contrasts with Zelboraf, which targets the BRAF protein kinase directly, and Yervoy, which targets a molecule found on the surface of T cells.

GSK also has its own drug that targets the BRAF protein kinase in the form of Tafinlar (dabrafenib), which was approved in the EU last year.

As well as marketing both drugs separately, GSK is looking to take advantage of the complementary actions of Tafinlar and Mekinist, winning FDA approval for a combination therapy at the beginning of 2014.

The company also has plans for a similar combination in the EU despite withdrawing its initial regulatory application last month following discussions with the EMA. A resubmission is planned for a later date once more trial data becomes available.

Although no other new drugs were recommended by the CHMP, it backed new indications for seven medicines, including a thyroid cancer indication for Bayer's Nexavar.

Article by
Thomas Meek

28th April 2014

From: Sales



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