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FDA approves GSK’s combo cancer treatment

US regulator backs Mekinist and Tafinlar to treat melanoma

GSK - logo on building 

GlaxoSmithKline (GSK) can now market two of its skin cancer drugs as part of a combination treatment in the US.

The US Food and Drug Administration (FDA) approved a combination of the pharma company's Mekinist (trametinib) and Tafinlar (dabrafenib) for the treatment of patients with unresectable or metastatic melanoma who have a certain genetic mutation.

The approval, which was hastened via an accelerate approval programme under a priority review designation, means that GSK can market the combination treatment in the indication for any patient who has either the BRAF V600E or V600K mutation, as detected by an FDA-approved test.

Available diagnostics include bioMerieux's THxID BRAF test, which was approved by the FDA as a companion diagnostic when Tafinlar and Mekinist were approved as individual treatments in March 2013.

At the time, they were the third and fourth new drugs for melanoma to be approved in recent years, after Daiichi Sankyo/ Roche's Zelboraf (vemurafenib) - which also targets BRAF-positive tumours - and Bristol-Myers Squibb's anti-CTLA4 immunotherapy Yervoy (ipilimumab).

Now Tafinlar and Mekinist can be used as part of the same treatment regimen in the US, with Dr Paolo Paoletti, president of oncology at GSK, explaining that each medicine targets a different mechanism in the body that regulates the growth of cancer cells.

He said: “We are proud that the first approved combination of targeted therapies in metastatic melanoma is Mekinist and Tafinlar, and our hope is that it will become part of the new standard of care for appropriate patients with BRAF V600E or V600K mutation-positive metastatic melanoma.”

With few treatment options available for melanoma patients prior to their launch, the recent batch of skin cancer drugs has got off to a successful start.

Yervoy made $706m for BMS in its first year on the market and is tipped to reach $2bn in annual sales at peak, while Roche reported Zelboraf revenues of about $286m for the first nine months of 2013.

Article by
Thomas Meek

9th January 2014

From: Sales

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