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Merck Announces Phase 3 KEYNOTE-A39/EV-302 Trial Met Dual Primary Endpoints of Overall Survival (OS) and Progression-Free Survival (PFS) in Certain Patients With Previously Untreated Locally Advanced or Metastatic Urothelial Cancer

First Phase 3 results for the KEYTRUDA® and Padcev® combination showed a statistically significant and clinically meaningful improvement in OS, PFS and key secondary endpoint of overall response.

United statesEliav barrSeagen padcevAgensys incStatement of merck co incExchange commissionSeagen incMerck co incMerck research laboratoriesMerck researchResponse evaluation criteriaSolid tumorsBacillus calmette guerin unresponsiveSelected important safetyImportant safety informationFatal immune mediated adverse

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 .

United statesGursel aktanDrug administrationStatement of merck co incMerck research laboratoriesMerck co incFoundation incExchange commissionEuropean network for gynaecological oncology trialBiologics license applicationPrescription drug user fee actMerck researchCombined positive scoreEuropean networkGynaecological oncology trialAmong merck

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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United statesGursel aktanPeter dannenbaumJulie cunninghamDamini chokshiJohn infantiDrug administrationStatement of merck co incMerck research laboratoriesMerck co incFoundation incExchange commissionEuropean network for gynaecological oncology trialBiologics license applicationPrescription drug user fee actMerck research

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 .

United statesEuropean network for gynaecological oncology trialFoundation incExchange commissionMerck co incStatement of merck co incCombined positive scoreEuropean networkGynaecological oncology trialAmong merckSelected important safetyImportant safety informationFatal immune mediated adverseWhich can present with diabeticNervous systemPatients with multiple

Merck & Co , Inc : Merck Receives Positive EU CHMP Opinion for KEYTRUDA (pembrolizumab) as Adjuvant Treatment for Adults with Non-Small Cell Lung Cancer at High Risk of Recurrence Following Complete Resection and Platinum-Based Chemotherapy

Merck & Co , Inc : Merck Receives Positive EU CHMP Opinion for KEYTRUDA (pembrolizumab) as Adjuvant Treatment for Adults with Non-Small Cell Lung Cancer at High Risk of Recurrence Following Complete Resection and Platinum-Based Chemotherapy
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United statesPeter dannenbaumGregory lubinieckiJulie cunninghamDamini chokshiExchange commissionMerck co incMerck research laboratoriesEuropean unionEuropean organisation for researchStatement of merck co incEuropean commissionEuropean medicines agencyMedicinal productsHuman useMerck research