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Merck Keytruda Gets EU Approval for First-Line Lung Cancer
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Merck & Co., Inc. (MRK - Free Report) announced that its anti-PD-1 therapy Keytruda has been approved by the European Commission for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC).
In Aug 2016, Keytruda was approved in the EU for the second-line treatment of advanced or metastatic NSCLC in patients whose tumors express PD-L1 and who have received at least one prior chemotherapy regimen. Meanwhile, the drug is already approved in the U.S. for the first-line NSCLC indication. Sales of the drug are projected to improve sharply following the latest approval.
The EU approval was supported by positive phase III data from KEYNOTE-024, a study that demonstrated superior overall survival (OS) and progression-free survival (PFS) of Keytruda compared to chemotherapy. The study was conducted in a total of 305 patients. In the study, Keytruda led to risk reduction of disease progression or death by 50% compared to chemotherapy.
With the approval, Keytruda can now be marketed in all 28 member countries of the EU in addition to Iceland, Lichtenstein and Norway.
Merck’s shares increased 5.3% this year, while the Zacks classified Large-Cap Pharma industry lost 1.7%. The outperformance was likely backed by consistently strong earnings results, along with a regular flow of positive news and regulatory updates.
Apart from lung cancer, Keytruda is approved in the U.S. for the treatment of patients with unresectable or metastatic melanoma until disease progression or unacceptable toxicity, and previously treated recurrent or metastatic head and neck cancer (HNSCC).
Keytruda is the first anti-PD-1 therapy to gain FDA approval and is being studied in more than 30 types of cancer. Merck is collaborating with several companies like Amgen, Inc. (AMGN - Free Report) , Incyte, GlaxoSmithKline plc (GSK - Free Report) and Pfizer Inc. (PFE - Free Report) for evaluating Keytruda in combination with other regimens. Over the last few months, the company has seen a series of positive news on Keytruda, raising sales expectations from the drug. Further label expansion of the drug would contribute significantly to Merck’s top line.
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Merck Keytruda Gets EU Approval for First-Line Lung Cancer
Merck & Co., Inc. (MRK - Free Report) announced that its anti-PD-1 therapy Keytruda has been approved by the European Commission for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC).
In Aug 2016, Keytruda was approved in the EU for the second-line treatment of advanced or metastatic NSCLC in patients whose tumors express PD-L1 and who have received at least one prior chemotherapy regimen. Meanwhile, the drug is already approved in the U.S. for the first-line NSCLC indication. Sales of the drug are projected to improve sharply following the latest approval.
The EU approval was supported by positive phase III data from KEYNOTE-024, a study that demonstrated superior overall survival (OS) and progression-free survival (PFS) of Keytruda compared to chemotherapy. The study was conducted in a total of 305 patients. In the study, Keytruda led to risk reduction of disease progression or death by 50% compared to chemotherapy.
With the approval, Keytruda can now be marketed in all 28 member countries of the EU in addition to Iceland, Lichtenstein and Norway.
Merck’s shares increased 5.3% this year, while the Zacks classified Large-Cap Pharma industry lost 1.7%. The outperformance was likely backed by consistently strong earnings results, along with a regular flow of positive news and regulatory updates.
Apart from lung cancer, Keytruda is approved in the U.S. for the treatment of patients with unresectable or metastatic melanoma until disease progression or unacceptable toxicity, and previously treated recurrent or metastatic head and neck cancer (HNSCC).
Keytruda is the first anti-PD-1 therapy to gain FDA approval and is being studied in more than 30 types of cancer. Merck is collaborating with several companies like Amgen, Inc. (AMGN - Free Report) , Incyte, GlaxoSmithKline plc (GSK - Free Report) and Pfizer Inc. (PFE - Free Report) for evaluating Keytruda in combination with other regimens. Over the last few months, the company has seen a series of positive news on Keytruda, raising sales expectations from the drug. Further label expansion of the drug would contribute significantly to Merck’s top line.
Merck & Company, Inc. Price
Merck & Company, Inc. Price | Merck & Company, Inc. Quote
Zacks Rank
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>>