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Merck's Keytruda Gets FDA Nod for Expanded Lung Cancer Group

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Merck & Co., Inc. MRK announced that the FDA granted approval to its blockbuster anti-PD-1 therapy, Keytruda for an expanded first-line lung cancer indication.

It is now approved, as a monotherapy, for first-line treatment of patients with stage III or metastatic non-small cell lung cancer (NSCLC) whose tumors expressed PD-L1 in at least 1% of tumor cells ((TPS of ≥1 percent), with no EGFR or ALK genomic tumor aberrations.

The approval was based on data from the phase III KEYNOTE-042 study. Data from the study demonstrated that Keytruda monotherapy led to a statistically significant improvement in overall survival compared to platinum-based chemotherapy in such patients.

Notably, Keytruda monotherapy is already marketed for the first-line treatment of patients with metastatic NSCLC whose tumors express PD-L1 protein levels of 50% or greater (TPS of ≥50%) based on data from the KEYNOTE-024 study. With the OS data from KEYNOTE-042 study approved to be included in Keytruda’s label, the drug can be prescribed to treat an expanded lung cancer patient population, further reinforcing its position in the lung cancer market.

Merck’s stock has risen 4.5% this year so far compared with 1.6% increase for the industry.



Keytruda is a key contributor to Merck’s sales. In a very short span of time, Keytruda has become Merck’s biggest product. It is already approved for use in 15 indications across 10 different tumor types in the United States. The drug generated sales of $7.17 billion in 2018, reflecting a massive 88% surge year over year.

Keytruda is continuously growing and expanding into new indications and markets globally. Sales of the drug are gaining particularly from strong momentum in the indication of first-line lung cancer as it is the only anti-PD-1 approved in the first-line setting in certain patients both as monotherapy as well as combination therapy.

The Keytruda development program is also progressing well and the drug is being studied for more than 30 types of cancer in more than 900 studies, including more than 600 combination studies. Merck is collaborating with several companies including Amgen AMGN, Incyte INCY, Glaxo (GSK - Free Report) and Pfizer separately for the evaluation of Keytruda in combination with other regimens. 

Several regulatory decisions for new indications in the United States as well as in Europe are pending in 2019, which, if approved, can further boost sales. 

Merck currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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