Merck & Co. Inc. MRK announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has rendered a positive opinion in favor of approving Keytruda in the EU for the first-line treatment as well as the treatment of previously treated advanced (unresectable or metastatic) melanoma patients.
The favorable opinion of the CHMP will now be reviewed by the European Commission. With the CHMP rendering a positive opinion, we believe chances of Keytruda gaining EU approval are high.
We note that Keytruda was the first anti-PD-1 therapy to gain approval in the U.S. last year for the treatment of patients suffering from unresectable or metastatic melanoma whose disease progressed after treatment with Bristol-Myers Squibb Company’s BMY Yervoy (ipilimumab) and a BRAF inhibitor, if the BRAF V600 mutation is positive.
Keytruda, which was approved last September, generated sales of $83 million in the first quarter of 2015, up 66% sequentially.
Meanwhile, Merck continues to work on expanding Keytruda’s label further. Last month, the company submitted a supplemental biologics license application (sBLA) to the FDA for the treatment of advanced non-small cell lung cancer. The company also plans to submit an sBLA for Keytruda for the first-line treatment of advanced melanoma based on KEYNOTE-006 study results by mid-2015.
Label expansion into additional indications would give Keytruda access to an expanded patient population and increase the commercial potential of the drug.
Merck currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector are Gilead Sciences Inc. GILD and Actelion Ltd. ALIOF. Both hold a Zacks Rank #1 (Strong Buy).
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