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Mercks KEYTRUDA (pembrolizumab) Significantly Improves Overall Survival Compared to Chemotherapy in Previously Treated Patients with Advanced Bladder (Urothelial) Cancer

2016-11-12 17:45:00| Merck.com - Product News

Dateline City: KENILWORTH, N.J. First Presentation of Data from Phase 3 KEYNOTE-045 Study Presented at the Society for Immunotherapy of Cancers (SITC) 31 st Annual Meeting KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced results from the pivotal KEYNOTE-045 study investigating the use of KEYTRUDA (pembrolizumab), the companys anti-PD-1 therapy, in patients with advanced bladder (urothelial) cancer previously treated with platinum-containing chemotherapy. As previously announced, KEYTRUDA was superior to investigator-choice chemotherapy for the primary endpoint of overall survival (OS) in this phase 3 study, and was stopped early. Language: English Contact: MerckMedia:Pamela Eisele, 267-305-3558orCourtney Ronaldo, 908-236-1108orInvestors:Teri Loxam, 908-740-1986orAmy Klug, 908-740-1898 Ticker Slug: Ticker: MRK Exchange: NYSE read more

Tags: advanced compared previously significantly

 

FDA Approves Mercks KEYTRUDA (pembrolizumab) in Metastatic NSCLC for First-Line Treatment of Patients Whose Tumors Have High PD-L1 Expression (Tumor Proportion Score [TPS] of 50 Percent or More) With No EGFR or ALK Genomic Tumor Aberrations

2016-10-25 00:04:00| Merck.com - Product News

Dateline City: KENILWORTH, N.J. KEYTRUDA is the Only Anti-PD-1 Therapy Approved in First-Line Treatment of Metastatic NSCLC; KEYTRUDA Demonstrated Superior Progression-Free and Overall Survival Compared to Chemotherapy in Patients Whose Tumors Expressed High Levels of PD-L1 FDA Also Approves a Labeling Update for KEYTRUDA for the Treatment of Patients with Metastatic NSCLC Whose Tumors Express PD-L1 (TPS of One Percent or More) With Disease Progression On or After Platinum-Containing Chemotherapy; Patients With EGFR or ALK Genomic Tumor Aberrations Should Have Disease Progression On FDA-Approved Therapy for These Aberrations Prior to Receiving KEYTRUDA KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA (pembrolizumab), the companys anti-PD-1 (programmed death receptor-1) therapy, for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (tumor proportion score [TPS] of 50 percent or more) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. Language: English Contact: MerckMedia:Pamela Eisele, 267-305-3558Courtney Ronaldo, 908-236-1108orInvestors:Teri Loxam, 908-740-1986Amy Klug, 908-740-1898 Ticker Slug: Ticker: MRK Exchange: NYSE read more

Tags: or with high treatment

 
 

FDA Approves Mercks ZINPLAVA (bezlotoxumab) to Reduce Recurrence of Clostridium difficile Infection (CDI) in Adult Patients Receiving Antibacterial Drug Treatment for CDI Who Are at High Risk of CDI Recurrence

2016-10-22 03:57:00| Merck.com - Corporate News

Dateline City: KENILWORTH, N.J. KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved ZINPLAVA (bezlotoxumab) Injection 25 mg/mL. Merck anticipates making ZINPLAVA available in first quarter 2017. Language: English Contact: MerckMedia:Pamela Eisele, 267-305-3558orRobert Consalvo, 908-236-1127orInvestors:Teri Loxam, 908-740-1986orAmy Klug, 908-740-1898 Ticker Slug: Ticker: MRK Exchange: NYSE read more

Tags: of high treatment risk

 

Mercks KEYNOTE-045 Studying KEYTRUDA (pembrolizumab) in Advanced Bladder Cancer (Urothelial Cancer) Meets Primary Endpoint and Stops Early

2016-10-21 12:45:00| Merck.com - Product News

Dateline City: KENILWORTH, N.J. KEYTRUDA is the First Immunotherapy to Show Improved Overall Survival Compared With Chemotherapy in Urothelial Cancer KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the phase 3 KEYNOTE-045 trial investigating the use of KEYTRUDA (pembrolizumab), the companys anti-PD-1 therapy, in patients with previously treated advanced urothelial cancer, met the primary endpoint of overall survival (OS). In this trial, KEYTRUDA was superior compared to investigator choice chemotherapy. Language: English Contact: MerckMedia:Pamela Eisele, 267-305-3558Courtney Ronaldo, 908-236-1108orInvestors:Teri Loxam, 908-740-1986Amy Klug, 908-740-1898 Ticker Slug: Ticker: MRK Exchange: NYSE read more

Tags: advanced early primary cancer

 

Two Major Studies to Be Presented at ESMO 2016 Congress Presidential Symposium Demonstrate Potential of Mercks KEYTRUDA (pembrolizumab) for the First-Line Treatment of Metastatic Non-Small Cell Lung Cancer in a Broad Range of Patients

2016-10-09 08:16:00| Merck.com - Product News

Dateline City: KENILWORTH, N.J. KEYNOTE-024, Published in The New England Journal of Medicine, Showed KEYTRUDA as Monotherapy Demonstrated Superior Progression-Free and Overall Survival Compared to Chemotherapy as First-Line Treatment in Patients with High Levels of PD-L1 Expression KEYNOTE-021, Cohort G, Published in The Lancet Oncology, Showed KEYTRUDA in Combination with Chemotherapy Demonstrated Superior Efficacy Compared to Chemotherapy Alone as First-Line Treatment; Trial Enrolled Patients Regardless of PD-L1 Expression KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced results from two major studies of KEYTRUDA (pembrolizumab), the companys anti-PD-1 therapy, in the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) at the ESMO 2016 Congress, the annual meeting of the European Society for Medical Oncology: Language: English Contact: Media:Pamela Eisele, 267-305-3558Kim Hamilton, 908-391-0131orInvestors:Teri Loxam, 908-740-1986Amy Klug, 908-740-1898 Ticker Slug: Ticker: MRK Exchange: NYSE read more

Tags: of range major potential

 

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