Merck & Co., Inc.’s MRK supplemental Biologics License Application (sBLA) for its anti-PD-1 therapy, Keytruda, has been accepted under priority review by the FDA.
Merck is looking to expand the label of Keytruda, in combination with chemotherapy (pemetrexed plus carboplatin), for the first-line treatment of patients with metastatic non-squamous non-small cell lung cancer (NSCLC), regardless of PD-L1 expression and with no EGFR or ALK genomic tumor aberrations. Note that this is the first sBLA filing for Keytruda as combination therapy. Also, if approved, it would be the first treatment option to combine chemotherapy with an immuno-oncology agentfor the treatment of advanced lung cancer.
Merck’s shares were up 11.5% in 2016, while the Zacks classified Large-Cap Pharma industry registered a decline of 5.6%. The company’s outperformance was backed by consistently strong earnings results, and positive news flow and regulatory updates. However, so far this year, shares of Merck rose 1.8%, lower than the 2.2% increase witnessed by the industry.
Coming back to the latest news, with the FDA granting priority review, a response should be out by May 10, 2017. The sBLA will be reviewed under the FDA’s accelerated approval program.
Keytruda ispresentlyapproved in the U.S. for the treatment of previously untreated metastatic NSCLC in patients whose tumors express high levels of PD-L1, and for previously treated metastatic NSCLC in patients whose tumors express PD-L1, as well as advanced melanoma, and previously treated recurrent or metastatic head and neck cancer (HNSCC).
New products like Keytruda have been contributing meaningfully to Merck’s top line, somewhat making up for the generic competition it faces for several drugs. Keytruda is the first anti-PD-1 therapy to gain FDA approval and is being studied for more than 30 types of cancer. Merck is collaborating with several companies including Amgen, Inc. AMGN, Incyte, GlaxoSmithKline plc GSK and Pfizer Inc. PFE separately for the evaluation of Keytruda in combination with their regimens. The last few months have seen a series of positive news regarding Keytruda, raising sales expectations for the drug. Importantly, the Oct 2016 approval of Keytruda for the first-line treatment of metastatic lung cancer was an important milestone for Merck and the drug’s sales are expected to improve hereafter. Further label expansion of Keytruda should significantly boost Merck’s top line significantly.
Merck currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Zacks' Top 10 Stocks for 2017
In addition to the stocks discussed above, would you like to know about our 10 finest buy-and-hold tickers for the entirety of 2017?
Who wouldn't? As of early December, the 2016 Top 10 produced 5 double-digit winners including oil and natural gas giant Pioneer Natural Resources which racked up a stellar +50% gain. The new list is painstakingly hand-picked from 4,400 companies covered by the Zacks Rank.Be among the very first to see it>>
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
Pfizer, Inc. (PFE): Free Stock Analysis Report
GlaxoSmithKline PLC (GSK): Free Stock Analysis Report
Merck & Company, Inc. (MRK): Free Stock Analysis Report
Amgen Inc. (AMGN): Free Stock Analysis Report
To read this article on Zacks.com click here.
Zacks Investment Research