Merck & Co., Inc. (MRK), GlaxoSmithKline plc (ADR) (GSK): Three FDA Stories You Missed Last Week

Glaxo’s triple feature

GlaxoSmithKline plc (ADR) (NYSE:GSK) received approval on May 29 for two melanoma drugs and a companion diagnostic. Melanoma is the most dangerous type of skin cancer, and GlaxoSmithKline plc (ADR) (NYSE:GSK)’s drugs treat melanoma that’s either late-stage or impossible to remove through surgery.

Tafinlar, formerly called dabrafenib, is a BRAF inhibitor that targets tumors with the genetic mutation BRAF V600E. Mekinist, formerly trametinib, is a MEK inhibitor that can target either V600E or V600K mutations. The concurrently approved test THxID BRAF tests which type of mutation a patient has to deliver the proper therapy.

Roche received approval for a similar setup back in 2011. The melanoma drug Zelboraf targets the V600E mutation and was approved jointly with its own companion diagnostic. Zelboraf had 2012 sales of 234 million CHF, or about $243 million U.S. dollars at current exchange rates. Mid-stage results seemed to indicate that GlaxoSmithKline plc (ADR) (NYSE:GSK)’s drugs could offer better efficacy than Zelboraf, but the drugs haven’t battled head-to-head in a trial.

The approvals will add fuel to the fire of GlaxoSmithKline plc (ADR) (NYSE:GSK)’s pipeline combo therapy using the two melanoma drugs. Combo therapy could offer better efficacy while also improving the safety profile.

Foolish final thoughts

Merck & Co., Inc. (NYSE:MRK) will lose the wind from its sails if the FDA agrees with the panel on suvorexant. The company’s still suffering from the patent loss of Singulair, and seemed to have a golden ticket with the insomnia drug. Celgene Corporation (NASDAQ:CELG)’s drug should fare better as it moves forward towards its PDUFA date.

But GlaxoSmithKline plc (ADR) (NYSE:GSK) is the public relations winner thanks to the approvals for one-third of its six key projects under review this year.

Brandy Betz has no position in any stocks mentioned. The Motley Fool recommends Celgene. Brandy is a member of The Motley Fool Blog Network — entries represent the personal opinion of the blogger and are not formally edited.

The article 3 FDA Stories You Missed This Week originally appeared on Fool.com is written by Brandy Betz.

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