GlaxoSmithKline Melanoma Drug Receives Accelerated Approval

GlaxoSmithKline

In this blog post, Sudhir Polisetty shares news about a new melanoma treatment option from GlaxoSmithKline that received accelerated FDA approval.

Welcome back to my melanoma blog, my name is Sudhir Polisetty and I am a dermatologist practicing in New Albany, Indiana. Early this morning, GlaxoSmithKline made headlines with its announcement that a new drug combination for treating melanoma received accelerated approval from United States regulators.

The Food and Drug Administration (FDA) approved two of the company’s drugs, Tafinlar (dabrafenib) and Mekinist (trametinib) to combined use in treating patients with unresectable melanoma or metastatic melanoma with BRAF inhibitors. Unresectable melanoma refers to legions that cannot be surgically removed while metastatic melanoma refers to melanoma that has spread to other parts of the body. BRAF inhibitors, where are mutations of a gene, have proven effective in shrinking melanoma tumors but patients eventually develop resistance to them. While Tafinlar and Mekinist have already been FDA-approved for separate use, GlaxoSmithKline believes melanoma will be held at bay longer by combining the two drugs.

FDA approval came after the drug combination showed promise in a Phase I/II study. Accelerated approval is dependent on the results of the ongoing Phase III trial, which will assess the clinical benefit of this drug combination in a patient population. The randomized Phase I/II open-label study evaluated single-agent dabrafenib (150mg) and the combination of the two drugs as the recommended dose (150/2mg).

Observed overall response rates were 76% for patients treated with the drug combination and just 54% for patients treated with only dabrafenib. The median duration of the response, or how long the results lasted, was 10.5 months for the drug combination and 5.6 months in patients treated with dabrafenib only. These results were supported by analyses conducted by the blinded independent radiologic review committee.

For more on this potential new treatment, take a look at the full press release on Market Watch: http://www.marketwatch.com/story/gsk-gains-accelerated-fda-approval-for-combination-use-of-mekinist-trametinib-and-tafinlar-dabrafenib-2014-01-08?reflink=MW_news_stmp

Thanks for reading,

Sudhir Polisetty

Learn more about me on MD.com, or keep up with other dermatology news by following me on Twitter: https://twitter.com/SudhirPolisetty

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