(CercleFinance.com) – Merck has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending the approval of KEYTRUDA.
It is Merck’s anti-PD-1 treatment for patients with microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) tumors in five different cancer types.
Recommendation Supports Use of KEYTRUDA in Certain Patients With Unresectable or Metastatic MSI-H/dMMR Colorectal, Gastric, Small Bowel, or Biliary Cancer, and MSI-H Endometrial Carcinoma /dMMR advanced or recurrent.
The CHMP recommendation was based on the results of the Phase 2 KEYNOTE-158 trial as well as the results of the Phase 2 KEYNOTE-164 trial, which also supported accelerated Food and Drug approval of KEYTRUDA Administration (FDA).
‘KEYTRUDA has already become an important first-line treatment option for some patients in Europe with MSI-H or dMMR colorectal cancer, and we are pleased that the CHMP has recommended KEYTRUDA as monotherapy for other patients with tumors MSI-H or dMMR. ‘ said Dr. Scot Ebbinghaus, Vice President, Global Clinical Development, Merck Research Laboratories.
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