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Merck Keytruda Gets CHMP Nod for First-Line Lung Cancer

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Merck & Co., Inc. (MRK - Free Report) announced that its anti-PD-1 therapy, Keytruda, was rendered a positive opinion in the EU for the first-line treatment of metastatic lung cancer.

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended marketing approval of Keytruda for the treatment of first-line non-small cell lung cancer (NSCLC) in patients whose tumors have high PD-L1 expression with no EGFR or ALK-positive tumor mutations. Note that the EMA generally takes the CHMP’s opinion into account while reviewing candidates, although it is not bound to abide by the same. A final decision from the European Commission is expected in the first quarter of 2017.

In the EU, Keytruda is approved for the second-line treatment of advanced or metastatic NSCLC whose tumors express PD-L1 and who have received at least one prior chemotherapy regimen.

We remind investors that this October, Keytruda received earlier-than-expected FDA approval for the first-line NSCLC indication. This was an important milestone for the company and Keytruda sales are projected to improve sharply with its approval in the first-line NSCLC indication.

Merck’s shares have soared 18.2% this year, while the Zacks classified Large-Cap Pharma industry lost 5.2%. The outperformance is likely backed by a consistently strong bottom-line performance, 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. In August, it was approved for 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 generic competition faced by several key drugs. 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) among others separately for the evaluation of 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 of the drug. Further label expansion of this key drug should contribute significantly to Merck’s top line.

Merck currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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