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GSK files combination skin cancer drug in US

Seeks FDA approval for Tafinlar - Mekinist combination in melanoma

GSK GlaxoSmithKline house

GlaxoSmithKline (GSK) has submitted a combination of its cancer drugs Tafinlar and Mekinist for US approval to treat metastatic melanoma.

Both drugs are already approved separately in the US alongside a companion diagnostic to treat the estimated 50 per cent of melanoma patients who have mutations in the BRAF gene, but GSK is pursuing the use of both treatments as a single therapy.

This is based on each drug's different method of action, with Tafinlar (dabrafenib) acting as a BRAF inhibitor, stopping the action of the BRAF enzyme that plays a role in the regulation of cell growth, while Mekinist (trametinib) inhibits both the MEK1 and MEK2 enzymes.

The combination submission covers the use of the drugs in patients with the BRAF V600 E or V600 K gene mutations, which is the same approval for Mekinist when used as a monotherapy.

Tafinlar is currently only approved for people with melanoma whose tumours express the BRAF V600E gene mutation.

The submission comes earlier than many analysts had expected, with GSK basing its application on relatively early data from a phase I/II study comparing Tafinlar monotherapy to combination therapy with both Tafinlar and Mekinist in patients with the gene mutations BRAF V600E and V600K.

Usually, data used to support regulatory submissions is based on later stage data from phase III trials, with this information not expected to be available for the Tafinlar/Mekinist combination until later this year.

If approved, the combination therapy would offer GSK further ammunition in the melanoma market, which has become a competitive one for pharma in recent years with the 2011 launches of Daiichi Sankyo/Roche's Zelboraf (vemurafenib) - which also targets BRAF-positive tumours - and Bristol-Myers Squibb's (BMS) anti-CTLA4 immunotherapy Yervoy (ipilimumab), which is not limited to patients with specific gene mutations.

This wider approval has helped BMS lead the way in the market, with Yervoy bringing in $706m in sales during 2012, while Roche reported sales of $244m for Zelboraf during the same period.

In Europe, a review of Mekinist, both as monotherapy and in combination with Tafinlar, is ongoing.

10th July 2013

From: Sales



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