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Merck (MRK) Gets FDA Nod for Keytruda in Esophageal Cancer

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Zacks Equity Research
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Merck & Co., Inc. MRK announced that FDA has approved its blockbuster PD-L1 inhibitor, Keytruda, for yet another new indication. Keytruda in combination with platinum- and fluoropyrimidine-based chemotherapy is now approved for the first-line treatment of esophageal and gastroesophageal junction (“GEJ”) carcinoma that is not amenable to surgical resection or definitive chemoradiation.

Following the nod by the FDA, Keytruda became the first anti-PD-1 therapy in combination with chemotherapy to be approved in the first-line setting of esophageal and GEJ carcinoma.

The approval was based on data from the phase III KEYNOTE-590 study which evaluated Keytruda plus fluorouracil (“FU”) and cisplatin in the given patient population. Data from the same showed that treatment with the Keytruda combo led to significant improvement in overall survival, progression-free survival and objective response rate, as compared to FU and cisplatin alone, regardless of histology or PD-L1 expression status.

Keytruda is presently approved as a monotherapy for the treatment of certain patients with esophageal cancer and GEJ adenocarcinoma.

Shares of Merck have declined 6.8% so far this year compared with the industry’s decrease of 0.2%.

price chart for MRK
price chart for MRK

We note that Keytruda is Merck’s major revenue-generating product. The drug recorded sales of $14.4 billion in 2020, up almost 30% year over year.

Keytruda is continuously growing and expanding into new indications and markets, globally. In fact, the Keytruda development program is also progressing well as the drug is being studied for more than 30 types of cancer in more than 1400 studies, including several combination studies.

Merck has collaborated with several companies, including Amgen AMGN, Glaxo GSK and Pfizer PFE, separately, for the evaluation of Keytruda in combination with other regimens.

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.

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Merck & Co., Inc. (MRK) : Free Stock Analysis Report

Amgen Inc. (AMGN) : Free Stock Analysis Report

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