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FDA Awards Supplemental Biologics License Application Priority Review to Merck’s (MRK) KEYTRUDA; Accepts KEYTRUDA Single Agent Application for Treating Endometrial Carcinoma

Tuesday, August 10, 2021 09:11 AM | Carl Pettit
FDA Awards Supplemental Biologics License Application Priority Review to Merck’s (MRK) KEYTRUDA; Accepts KEYTRUDA Single Agent Application for Treating Endometrial Carcinoma

What’s Going on with Merck?

Two big announcements came out of Merck (MRK) today, August 10, in relation to KEYTRUDA. First off, the FDA awarded Merk a priority review for a new supplemental Biologics License Application for KEYTRUDA regarding renal cell carcinoma (RCC). Additionally, the FDA accepted for review a new supplemental Biologics License Application requesting approval for KEYTRUDA “as a single agent for the treatment of patients with advanced endometrial carcinoma.”

Pre-market this morning, MRK stock held fairly steady, trading at $75.44 a share, which is a 0.16% increase in value.

What Does This Mean for MRK?

According to one of today’s press releases, “the U.S. Food and Drug Administration (FDA) has accepted and granted priority review for a new supplemental Biologics License Application” for KEYTRUDA “for the adjuvant treatment of patients with renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence following nephrectomy (surgical removal of a kidney), or following nephrectomy and resection of metastatic lesions."

Merk also revealed that the FDA has accepted for review a new supplemental Biologics License Application looking for approval for KEYTRUDA “as a single agent for the treatment of patients with advanced endometrial carcinoma that is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.”

“The acceptance of our application [to treat RCC]  demonstrates the progress we are making in earlier lines and earlier stages of certain cancers across our oncology portfolio,” Dr. Scot Ebbinghaus, vice president, clinical research at Merck Research Laboratories, commented. Dr. Ebbinghaus also noted that the FDA’s acceptance of the new supplemental Biologics License Application related to endometrial carcinoma added to the company’s “momentum of advancing new treatment options to address the most challenging cancers facing women.”

Fundamental Score - 63

MRK has a Fundamental Rank of 63. Find out what this means to you and get the rest of the rankings on MRK!

Merck makes pharmaceutical products to treat several conditions in a number of therapeutic areas, including cardiometabolic disease, cancer, and infections. Within cancer, the firm's immuno-oncology platform is growing as a major contributor to overall sales. The company also has a substantial vaccine business, with treatments to prevent hepatitis B and pediatric diseases as well as HPV and shingles. Additionally, Merck sells animal health-related drugs. From a geographical perspective, close to half of the firm's sales are generated in the United States.

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