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FDA Grants Priority Review to Merck's Application for KEYTRUDA® (pembrolizumab) Plus Concurrent Chemoradiotherapy as Treatment for Patients With Newly Diagnosed High-Risk Locally Advanced Cervical Cancer

Acceptance based on results from the Phase 3 KEYNOTE-A18 trial, which showed a statistically significant and clinically meaningful improvement in progression-free survival in these patients

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Merck (MRK) Granted FDA Priority Review for KEYTRUDA Plus Concurrent Chemoradiotherapy as Treatment for Patients With Newly Diagnosed High-Risk Locally Advanced Cervical Cancer

Merck (MRK) Granted FDA Priority Review for KEYTRUDA Plus Concurrent Chemoradiotherapy as Treatment for Patients With Newly Diagnosed High-Risk Locally Advanced Cervical Cancer
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FDA Grants Priority Review to Merck's Application for KEYTRUDA (pembrolizumab) Plus Concurrent Chemoradiotherapy as Treatment for Patients With Newly Diagnosed High-Risk Locally Advanced Cervical Cancer

20.09.2023 - Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has accepted for priority review a new supplemental Biologics License Application (sBLA) seeking approval for . ....

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Merck Announces Phase 3 KEYNOTE-A18 Trial Met Primary Endpoint of Progression-Free Survival in Patients with Newly Diagnosed High-Risk Locally Advanced Cervical Cancer

RAHWAY - Merck , known as MSD outside of the United States and Canada, today announced that the Phase 3 KEYNOTE-A18 trial, also known as ENGOT-cx11/GOG-3047, investigating KEYTRUDA, Merck s anti-PD-1. ....

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Merck Announces Phase 3 KEYNOTE-A18 Trial Met Primary Endpoint of Progression-Free Survival (PFS) in Patients With Newly Diagnosed High-Risk Locally Advanced Cervical Cancer

KEYTRUDA® (pembrolizumab) plus concurrent chemoradiotherapy demonstrated statistically significant and clinically meaningful improvement in PFS versus concurrent chemoradiotherapy alone in these patients ....

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