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Merck ‘s KEYTRUDA® Gains Positive Committee for Medicinal Products for Human Use of the European Medicines Agency Approval

By John F. Heerdink, Jr.

Merck & Co., Inc.  (MRK) known as MSD outside the United States and Canada recently announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has released a positive opinion for the approval of KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the first-line treatment of adult patients suffering from metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer based on the pivotal Phase 3 KEYNOTE-177 trial.

The trials showed that KEYTRUDA, as a monotherapy, demonstrated a significant improvement in progression-free survival compared to chemotherapy.

“Patients in Europe with MSI-H/dMMR colorectal cancer have had only chemotherapy-containing regimens available to them in the first-line treatment setting and have historically faced poor outcomes,”  “This positive EU CHMP opinion reinforces the potential of KEYTRUDA as a new option for patients with MSI-H/dMMR colorectal cancer and illustrates our ongoing commitment to pursuing biomarker research to help address the needs of patients who have few effective options.” stated Dr. Vicki Goodman, vice president, clinical research, Merck Research Laboratories.

The CHMP’s suggestion will now be reviewed and studied by the European Commission for marketing authorization in the European Union, and a final decision is expected in the first quarter of 2021.

Merck & Co., Inc.  (MRK) is a global healthcare solutions provider that has been working towards bringing forward medicine and vaccines for some of the world’s most challenging diseases for more than a century.  They are committed to increasing health care access and continue to be at the leading edge of research. Merck has the industry’s largest immuno-oncology clinical research program. To learn more about Merck (MRK) and to track its ongoing progress please visit the Vista Partners Merck Coverage Page.

If you liked this story please consider, visiting the Atossa Therapeutics (ATOS) dedicated page at Vista Partners to learn about the Seattle-based biotech firm’s work towards finding therapeutic treatments for Breast Cancer and the Coronavirus. 

Vista Partners LLC (”Vista”) is a California Registered Investment Advisor based in San Francisco. Vista delivers timely and relevant insights via the website: www.vistapglobal.com with daily stories, weekly market updates, monthly macroeconomic newsletters, podcasts, & Vista’s proprietary equity and market research to help you stay informed and stay competitive. Vista’s mission is to invest partner capital while arming investors with a comprehensive global financial perspective across all market sectors. Vista also seeks to provide select issuers with actionable advice regarding fundamental development, corporate governance, and capital market directives.

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Post View Count : 127
(Read Original Story: Merck Receives Positive EU CHMP Opinion for KEYTRUDA® (pembrolizumab) as First-Line Treatment in Adult Patients With Metastatic Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Colorectal Cancer in Business Wire)


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