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Health Canada Approves KEYTRUDA® (pembrolizumab) as First-line Treatment for Adults with Metastatic Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer


KEYTRUDA
® is an anti-PD-1 therapy that works by helping increase the ability of the body s immune system to help detect and fight tumour cells.
1
An estimated 26,900 Canadians were diagnosed with colorectal cancer in 2020, with an average of 73 Canadians diagnosed daily.
2
KIRKLAND, QC, March 8, 2021 /CNW/ - Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that Health Canada has approved KEYTRUDA
® (pembrolizumab), Merck s anti-PD-1 therapy, for the first-line treatment, as monotherapy, for adult patients with metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC).
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This approval offers a new first-line treatment option for patients with MSI-H/dMMR metastatic colorectal cancer, said Dr. Ron Burkes, Professor of Medicine, University of Toronto and Medical Oncologist, Mount Sinai Hospital. ....

United States , Alannah Nugent , Anna Van Acker , Ron Burkes , Barryd Stein , National Cancer Institute , Merck Co , Statement Of Merck Co , Exchange Commission , University Of Toronto , Merck Co Inc , Canadian Cancer Society , Canadian Agency For Drugs , Surveillance Research Program , Health Canada , Technologies In Health , Merck Research Program , Approval Based , Significant Progression Free Survival Findings , Medical Oncologist , Mount Sinai , Colorectal Cancer , Merck Oncology , Looking Statement , Securities Litigation Reform Act , Updated March ,

Health Canada Approves KEYTRUDA® as First-line Treatment for Adults with Metastatic Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer


Approval Based on Significant Progression Free Survival Findings from Phase 3 KEYNOTE-177 Trial KEYTRUDA ® is an anti-PD-1 therapy that works by helping increase the ability of the body’s immune system to help detect and fight tumour cells. 1 An estimated 26,900 Canadians were diagnosed with colorectal cancer in 2020, with an average of 73 Canadians diagnosed daily. 2  Merck known as MSD outside the United States …
Approval Based on Significant Progression Free Survival Findings from Phase 3 KEYNOTE-177 Trial
KEYTRUDA
® is an anti-PD-1 therapy that works by helping increase the ability of the body’s immune system to help detect and fight tumour cells.
1
An estimated 26,900 Canadians were diagnosed with colorectal cancer in 2020, with an average of 73 Canadians diagnosed daily. ....

United States , Anna Van Acker , Ron Burkes , Barryd Stein , National Cancer Institute , Merck Co , Statement Of Merck Co , Exchange Commission , University Of Toronto , Merck Co Inc , Canadian Cancer Society , Canadian Agency For Drugs , Surveillance Research Program , Health Canada , Technologies In Health , Merck Research Program , Approval Based , Significant Progression Free Survival Findings , Medical Oncologist , Mount Sinai , Colorectal Cancer , Merck Oncology , Looking Statement , Securities Litigation Reform Act , Mismatch Repair Deficiency Testing , Research Program ,

Merck & Co., Inc.: European Commission Approves KEYTRUDA (pembrolizumab) as First-Line Treatment in Adult Patients With Metastatic Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Colorectal Cancer


(2)
KEYTRUDA Is First Checkpoint Inhibitor Approved in Europe to Treat MSI-H or dMMR Colorectal Cancer
European Approval Based on Results From KEYNOTE-177 Trial Demonstrating KEYTRUDA Significantly Reduced Risk of Disease Progression or Death by 40% Compared With Chemotherapy
Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the European Commission has approved KEYTRUDA, Merck s anti-PD-1 therapy, as a monotherapy for the first-line treatment of adult patients with metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer. This approval is based on results from the pivotal Phase 3 KEYNOTE-177 trial, in which KEYTRUDA monotherapy significantly reduced the risk of disease progression or death by 40% (HR=0.60 [95% CI, 0.45-0.80]; p=0.0002) compared with chemotherapy (investigator s choice: mFOLFOX6 [oxaliplatin, leucovorin and fluorouracil (FU)] with or without bevacizumab or cetuxima ....

United States , France General , United Kingdom , Northern Ireland , Great Britain , Scot Ebbinghaus , Courtney Ronaldo , Peter Dannenbaum , Patrick Ryan , Thierry Andre , National Cancer Institute , Merck Research Laboratories , European Commission , Statement Of Merck Co Inc , Exchange Commission , Merck Co Inc , Sorbonne University , European Union , First Checkpoint Inhibitor Approved , Approval Based , Results From , Reduced Risk , Disease Progression , Compared With , Antoine Hospital , Merck Research ,