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FDA Approves Updated Indication for Merck s KEYTRUDA® for Treatment of Certain Patients With Urothelial Carcinoma

FDA Approves Updated Indication for Merck s KEYTRUDA® for Treatment of Certain Patients With Urothelial Carcinoma
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United statesScot ebbinghausKristen drakePeter dannenbaumMelissa moodyMerck research laboratoriesDrug administrationStatement of merck co incMerck co incExchange commissionOncologic drugs advisory committeePatients with locally advancedCombined positive scoreDrugs advisory committeeMerck researchBacillus calmette guerin unresponsive

FDA Approves KEYTRUDA® Plus LENVIMA® Combination for First-Line Treatment of Adult Patients With Advanced Renal Cell Carcinoma

KEYTRUDA Plus LENVIMA Is Now Approved for Two Types of Cancer, Including Advanced RCC Based on Phase 3 CLEARKEYNOTE-581 Trial, KEYTRUDA Plus LENVIMA Significantly Reduced Risk of Disease Progression or Death by 61% Versus Sunitinib Merck known as MSD outside the United States and Canada, and Eisai today announced that the U.S. Food and Drug Administration has approved the combination of KEYTRUDA, Merck’s anti-PD-1 .

United statesNew zealandGregory lubinieckiNikki sullivanDorothy byrnePeter dannenbaumMelissa moodyRobert motzerOncology clinical researchEisai europe ltdStatement of merck co incMerck co incSustainable development goalsMerck research laboratoriesDrug administrationEisai inc

FDA Grants Priority Review to Merck s Supplemental Biologics License Application for KEYTRUDA® as Adjuvant Therapy in Certain Patients With Renal Cell Carcinoma Following Surgery

FDA Grants Priority Review to Merck s Supplemental Biologics License Application for KEYTRUDA® as Adjuvant Therapy in Certain Patients With Renal Cell Carcinoma Following Surgery
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United statesScot ebbinghausPeter dannenbaumMelissa moodyJustine mooreMerck research laboratoriesAmerican society of clinical oncologyDrug administrationStatement of merck co incMerck co incExchange commissionApplication basedBiologics license applicationClinical oncologyPrescription drug user fee actMerck research

FDA Accepts Application for Merck s KEYTRUDA® as Single Agent for Certain Patients With MSI-H/dMMR Advanced Endometrial Carcinoma

FDA Accepts Application for Merck s KEYTRUDA® as Single Agent for Certain Patients With MSI-H/dMMR Advanced Endometrial Carcinoma
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United statesScot ebbinghausPeter dannenbaumMelissa moodyMerck research laboratoriesDrug administrationStatement of merck co incExchange commissionMerck co incEuropean society for medical oncologyData supporting applicationBiologics license applicationEuropean societyMedical oncologyPrescription drug user fee actMerck research

Merck s KEYTRUDA® Significantly Prolonged Recurrence-Free Survival Compared to Placebo as Adjuvant Therapy for Patients With Stage II Resected High-Risk Melanoma in Phase 3 KEYNOTE-716 Trial

Merck s KEYTRUDA® Significantly Prolonged Recurrence-Free Survival Compared to Placebo as Adjuvant Therapy for Patients With Stage II Resected High-Risk Melanoma in Phase 3 KEYNOTE-716 Trial
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United statesPeter dannenbaumRoy baynesMelissa moodyMerck research laboratoriesDrug administrationStatement of merck co incExchange commissionMerck co incPriority reviewThese dataBiologics license applicationPrescription drug user fee actMerck researchNeck squamous cell cancerBacillus calmette guerin unresponsive