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Merck (MRK) Gets FDA's Priority Review for Another Keytruda sBLA

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Zacks Equity Research
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Merck & Co., Inc. MRK announced that that the FDA has accepted its supplemental biologics license application (sBLA) seeking approval of its blockbuster anti-PD-1 therapy, Keytruda, for newly diagnosed esophageal and gastroesophageal junction (“GEJ”) cancer. The company is seeking an approval for Keytruda in combination with platinum and fluoropyrimidine-based chemotherapy for the first-line treatment of patients with locally advanced unresectable/metastatic esophageal and GEJ cancer.

With the FDA granting a priority review to the sBLA, a decision from the regulatory body is expected on Apr 13, 2021.

The sBLA was based on data from the pivotal phase III KEYNOTE-590 study which evaluated Keytruda plus chemotherapy for treating esophagus and GEJ cancer in the first-line setting. Data from the study showed that treatment with the Keytruda combo led to significant improvements in overall survival and progression-free survival – the primary endpoints, as compared to patients who received only chemotherapy regardless of their PD-L1 expression status and tumor histology.

Per the company, despite current available treatments, patients with esophageal and GEJ cancer in the first-line setting often face an aggressive disease with a poor prognosis. If approved, the Keytruda combo can become a new treatment option for the given patient population.

Notably, Keytruda as a monotherapy is already approved for the second-line treatment of recurrent locally advanced/metastatic squamous cell carcinoma of the esophagus in patients whose tumors express PD-L1 in the United States, China and Japan.

Shares of Merck have declined 12.2% so far this year against the industry’s increase of 2.2%.

price chart for MRK
price chart for MRK

Merck’s biggest product, Keytruda, is already approved for treating 30 indications across several different tumor types in the United States. The drug recorded sales of $10.4 billion in the first nine months of 2020, up 30.3% year over year, driven by continuous label expansion into various new indications.

We note that the Keytruda development program is also progressing well with Merck, spending billions of dollars on research and development of this medicine to secure more approvals in earlier lines of treatment. The drug is being studied for more than 30 types of cancer in over 1300 studies including 900 plus combination studies. Meanwhile, Merck has collaborated with several companies including Glaxo GSK, Amgen AMGN, Pfizer PFE separately for the evaluation of Keytruda in combination with other regimens.

Zacks Rank

Merck currently has 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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