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Two New Trials of Mercks KEYTRUDA (pembrolizumab) as Monotherapy and in Combination with Chemotherapy for First-Line Treatment of Patients with Advanced Non-Small Cell Lung Cancer to be Presented During Presidential Session at ESMO 2016

2016-09-28 12:45:00| Merck.com - Corporate News

Dateline City: KENILWORTH, N.J. Results from KEYNOTE-024, which Studied KEYTRUDA Compared to Chemotherapy in Patients with High Levels of PD-L1 Expression, and KEYNOTE-021G, which Studied KEYTRUDA in Combination with Chemotherapy Compared to Chemotherapy Alone in Patients Regardless of PD-L1 Expression, to be Presented Comprehensive Data from Mercks Industry-Leading Immuno-Oncology Clinical Development Program to be Presented, with New Data in 12 Cancers KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that extensive data on KEYTRUDA (pembrolizumab), the companys anti-PD-1 therapy, have been accepted for presentation at the European Society for Medical Oncology (ESMO) 2016 Congress in Copenhagen, Denmark, Oct. 7 11. In total, findings from 30 studies in 12 cancers from Mercks industry-leading clinical development program for KEYTRUDA both as monotherapy and in combination will be presented at this years ESMO. Language: English Contact: MerckMedia:Pamela Eisele, 267-305-3558Kim Hamilton, 908-740-1863orInvestors:Teri Loxam, 908-740-1986Amy Klug, 908-740-1898 Ticker Slug: Ticker: MRK Exchange: NYSE read more

Tags: to advanced presented cell

 

FDA Accepts Supplemental Biologics License Application, Assigns Priority Review and Grants Breakthrough Therapy Designation to Mercks KEYTRUDA (pembrolizumab) for First-Line Treatment of Patients with Advanced Non-Small Cell Lung Cancer

2016-09-07 12:45:00| Merck.com - Product News

Dateline City: KENILWORTH, N.J. Merck Has Also Submitted a Marketing Authorization Application to the European Medicines Agency for KEYTRUDA in the Same Patient Population Submissions Based on Data from KEYNOTE-024 Trial Showing Superior Progression-Free and Overall Survival Compared to Chemotherapy in Patients Whose Tumors Express High Levels of PD-L1 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 accepted for Priority Review the supplemental Biologics License Application (sBLA) for KEYTRUDA (pembrolizumab), the companys anti-PD-1 therapy, for the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors express PD-L1, with a PDUFA, or target action, date of Dec. 24, 2016. 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 review application license

 
 

Results from Mercks Phase 3 Study Evaluating ZEPATIER (elbasvir and grazoprevir) in Patients with Chronic Hepatitis C Receiving Treatment for Opioid Dependence Published in Annals of Internal Medicine

2016-08-08 23:05:00| Merck.com - Product News

Dateline City: KENILWORTH, N.J. KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the publication of results from C-EDGE CO-STAR . C-EDGE CO-STAR is a Phase 3 trial evaluating the use of ZEPATIER (elbasvir and grazoprevir) 50mg/100mg tablets in patients with chronic hepatitis C (HCV) genotype (GT) 1, GT4 and GT6 infection receiving opioid agonist therapy (OAT) (methadone and buprenorphine), commonly used to treat opioid addiction. Language: English Contact: MerckMedia:Pamela Eisele, 267-305-3558orSarra Herzog, 201-669-6570orInvestor:Teri Loxam, 908-740-1986orAmy Klug, 908-740-1898 Ticker Slug: Ticker: MRK Exchange: NYSE read more

Tags: in of results study

 

FDA Approves Mercks KEYTRUDA (pembrolizumab) for Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma with Disease Progression on or After Platinum-Containing Chemotherapy

2016-08-08 12:45:00| Merck.com - Product 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 KEYTRUDA (pembrolizumab), the companys anti-PD-1 (programmed death receptor-1) therapy, at a fixed dose of 200 mg every three weeks, for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy. Language: English Contact: MerckMedia:Pamela Eisele, 267-305-3558orAn Phan, 908-255-6325orInvestor:Teri Loxam, 908-740-1898orAmy Klug, 908-740-1898 Ticker Slug: Ticker: MRK Exchange: NYSE read more

Tags: or head cell disease

 

FDA Approves Mercks KEYTRUDA (pembrolizumab) for Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma with Disease Progression on or After Platinum-Containing Chemotherapy

2016-08-06 01:30:00| Merck.com - Product 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 KEYTRUDA (pembrolizumab), the companys anti-PD-1 (programmed death receptor-1) therapy, at a fixed dose of 200 mg every three weeks, for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy. Language: English Contact: MerckMedia:Pamela Eisele, 267-305-3558orAn Phan, 908-255-6325orInvestor:Teri Loxam, 908-740-1898orAmy Klug, 908-740-1898 Ticker Slug: Ticker: MRK Exchange: NYSE read more

Tags: or head cell disease

 

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