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FDA Accepts Supplemental Biologics License Application (sBLA) for KEYTRUDA (pembrolizumab), Mercks Anti-PD-1 Therapy, in Advanced Non-Small Cell Lung Cancer, and Grants Priority Review
2015-06-01 22:34:00| Merck.com - Product News
Dateline City: KENILWORTH, N.J. KEYNOTE-001 Data Served as the Basis for U.S. FDA Filing and Breakthrough Therapy Designation in Advanced NSCLC Across Histologies 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 review the supplemental Biologics License Application (sBLA) for Mercks anti-PD-1 therapy, KEYTRUDA (pembrolizumab), for the treatment of patients with advanced non-small cell lung cancer (NSCLC) whose disease has progressed on or after platinum-containing chemotherapy and an FDA-approved therapy for EGFR or ALK genomic tumor aberrations, if present. Language: English Contact: MerckMedia:Pamela Eisele, 267-664-0282Claire Mulhearn, 908-200-1889orInvestors:Joseph Romanelli, 908-740-1986Justin Holko, 908-740-1879 Ticker Slug: Ticker: MRK Exchange: NYSE read more
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New Findings Show Durable Anti-Tumor Activity with KEYTRUDA (pembrolizumab), Mercks Anti-PD-1 Therapy, in Patients with Advanced Head and Neck Cancer, Regardless of PD-L1 Expression Status
2015-05-29 20:06:00| Merck.com - Product News
Dateline City: KENILWORTH, N.J. Results from KEYNOTE-012, the First and Largest Study to Date of an Anti-PD-1 Therapy in Head and Neck Cancer, to be Presented at 2015 ASCO Annual Meeting KEYTRUDA Monotherapy Achieved Overall Response Rate of 25 Percent in Heavily Pre-treated Patients Merck is Advancing a Broad Head and Neck Clinical Program for KEYTRUDA with Five Clinical Trials, Across Multiple Lines of Therapy and in Combination with Other Agents KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced new investigational data evaluating KEYTRUDA (pembrolizumab), the companys anti-PD-1 therapy, as a monotherapy from the KEYNOTE-012 Phase 1b study in 132 pre-treated patients with recurrent or metastatic head and neck cancer, regardless of PD-L1 expression status. Language: English Contact: MerckMedia:Pamela Eisele, 267-664-0282Claire Mulhearn, 908-200-1889orInvestors:Joseph Romanelli, 908-740-1986Justin Holko, 908-740-1879 Ticker Slug: Ticker: MRK Exchange: NYSE read more
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First Study Evaluating DNA Mismatch Repair as Genetic Guide for Immunotherapy Treatment with Mercks KEYTRUDA (pembrolizumab) Presented at 2015 ASCO Annual Meeting and Published in the New England Journal of Medicine
2015-05-29 20:05:00| Merck.com - Product News
Dateline City: KENILWORTH, N.J. Early Findings Show DNA Mismatch Repair-Deficient Colorectal and Other Tumors Highly Responsive to Checkpoint Blockade with Anti-PD-1 Therapy Merck Plans to Initiate Phase 2 Registrational Study with KEYTRUDA (KEYNOTE-164) to Evaluate MMR-Deficiency in Colorectal Cancer KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced results from the first study evaluating the correlation of benefit with an immunotherapy based on DNA mismatch repair (MMR) deficiency, a well-established form of genetic instability in many cancers characterized by the loss of function of the MMR pathway. Language: English Contact: MerckMedia:Pamela Eisele, 267-664-0282Claire Mulhearn, 908-200-1889orInvestors:Joseph Romanelli, 908-740-1986Justin Holko, 908-740-1879 Ticker Slug: Ticker: MRK Exchange: NYSE read more
2015 ASCO Annual Meeting: New Data in 10 Different Cancers from Mercks Rapidly Expanding Immuno-Oncology Research Program for KEYTRUDA (pembrolizumab) to be Presented
2015-05-13 23:00:00| Merck.com - Corporate News
Dateline City: KENILWORTH, N.J. New Findings Show Anti-tumor Activity of KEYTRUDA in Five Additional Cancers: Colorectal, Esophageal, Ovarian, Renal Cell Carcinoma and Small-Cell Lung Cancer First-Time Presentations of DNA Mismatch Repair Deficiency Data in Colorectal and other Cancers and Nanostring RNA Data in Melanoma, Head and Neck and Gastric Cancers Industry-leading Number of PD-1 Clinical Trials Resulting in Growing Body of Data for KEYTRUDA across 13 Tumor Types KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that new investigational data in 10 different types of cancer from the companys immuno-oncology development program evaluating its anti-PD-1 therapy, KEYTRUDA (pembrolizumab), will be presented at the 51st Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, May 29 June 2, 2015. Language: English Contact: MerckMedia:Pamela Eisele, 267-305-3558Claire Mulhearn, 908-236-1118orInvestors:Joseph Romanelli, 908-740-1986Justin Holko, 908-740-1879 Ticker Slug: Ticker: MRK Exchange: NYSE read more
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Mercks Pivotal Phase 3 C-EDGE Program Evaluating Grazoprevir/Elbasvir Shows High Sustained Virologic Responses Across Broad Range of Patients with Chronic Hepatitis C Virus Infection
2015-04-24 07:00:00| Merck.com - Research & Development News
Dateline City: VIENNA Data Sets Include Treatment-Nave, Treatment-Experienced and HIV Co-Infected Patients with Chronic Hepatitis C Virus Genotypes 1, 4 or 6 Infection Merck Remains on Track to Submit New Drug Application (NDA) to U.S. Food and Drug Administration (FDA) in First Half of 2015 VIENNA--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced the first presentations of data from the companys ongoing C-EDGE pivotal Phase 3 clinical trial program evaluating the investigational once-daily tablet grazoprevir/elbasvir (100mg/50mg) in patients with or without cirrhosis who are infected with chronic hepatitis C virus (HCV) genotypes 1, 4 or 6 (GT1, 4 or 6).1 Patients in both the HCV infected, treatment-nave (C-EDGE TN), and HIV/HCV co-infected, treatment-nave (C-EDGE CO-INFXN
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