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Merck's Keytruda under FDA Review for First-Line Melanoma

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Merck & Co. Inc. (MRK - Free Report) announced that the FDA has accepted its supplemental Biologics License Application (sBLA) for Keytruda, an anti-PD-1 therapy, for review. The company is seeking approval of the currently approved dose of the drug (2mg every three weeks) for the first-line treatment of patients with unresectable or metastatic melanoma. The FDA granted Priority Review with an action date of Dec 19, 2015.

Merck also announced that the FDA has extended the review period for another sBLA for Keytruda. The FDA now expects to give a response regarding the approval of Keytruda for the treatment of patients with Yervoy (ipilimumab)-refractory advanced melanoma by Dec 24.

We note that Keytruda is currently approved for the treatment of patients with unresectable or metastatic melanoma and disease progression following Yervoy and, if BRAF V600 mutation positive, a BRAF inhibitor.  The company generated Keytruda sales of $192 million in the first half of 2015.

According to the press release issued by the company, the five-year survival rate for advanced or metastatic melanoma (stage IV) is estimated to be 15% to 20% in the U.S. About 73,870 people are estimated to be diagnosed with the disease this year in the U.S.

Meanwhile, Merck continues to progress on its additional studies on Keytruda. Currently, the company is evaluating Keytruda, both as monotherapy and in combination with other therapies in as many as 100 clinical studies, across more than 30 tumor types.

Keytruda is currently under FDA review for the treatment of patients with advanced non-small cell lung cancer (NSCLC) whose disease progressed on or after platinum-containing chemotherapy and an FDA approved therapy for EGFR or ALK genomic tumor aberrations, if present. A response from the agency should be out by Oct 2.

Other players in the market include Bristol-Myers Squibb Company’s (BMY - Free Report) a PD-1 immune checkpoint inhibitor, Opdivo, which is also approved for two cancer indications – for the treatment of patients with unresectable or metastatic melanoma and disease progression following Yervoy and, if BRAF V600 mutation positive, a BRAF inhibitor and for the treatment of patients with metastatic squamous NSCLC with progression on or after platinum-based chemotherapy. Currently, the company’s sBLA for first-line treatment of melanoma patients is under FDA review with an action date of Nov 27.

Merck carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Gilead Sciences Inc. (GILD - Free Report) and AMAG Pharmaceuticals, Inc. (AMAG - Free Report) , each sporting a Zacks Rank #1 (Strong Buy).

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