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Tag: mercks
FDA Accepts Two sBLAs for Mercks KEYTRUDA (pembrolizumab) for Locally Advanced or Metastatic Urothelial Cancer in Cisplatin-Ineligible First-Line and Second-Line Post-Platinum Failure Treatment Settings
2017-02-03 12:45:00| Merck.com - Product News
Dateline City: KENILWORTH, N.J. KEYTRUDA Also Receives Breakthrough Therapy Designation for Second-Line Treatment Based on KEYNOTE-045, Which Includes Primary Endpoints of Overall Survival and Progression-Free Survival 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 two supplemental Biologics License Applications (sBLAs) for KEYTRUDA (pembrolizumab), the companys anti-PD-1 therapy, in patients with locally advanced or metastatic urothelial cancer, a type of bladder cancer. Language: English Contact: For 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 @Merck read more
Tags: advanced
treatment
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failure
European Medicines Agencys CHMP Recommends Mercks KEYTRUDA (pembrolizumab) for the First-Line Treatment of Patients with Metastatic Non-Small Cell Lung Cancer (NSCLC) Whose Tumors Have High PD-L1 Expression with No EGFR or ALK Positive Tumor...
2016-12-16 13:26:00| Merck.com - Product News
Dateline City: KENILWORTH, N.J. Opinion Based on Findings from KEYNOTE-024 Trial, Which Showed Superior Overall Survival and Progression Free Survival with KEYTRUDA Compared to Chemotherapy First Anti-PD-1 Therapy to Receive a CHMP Positive Opinion for Previously Untreated Patients with Metastatic NSCLC KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of KEYTRUDA (pembrolizumab), the companys anti-PD-1 therapy, for the first-line treatment of metastatic non-small cell lung cancer (NSCLC) in adults whose tumors have high PD-L1 expression (tumor proportion score [TPS] of 50 percent or more) with no EGFR or ALK positive tu 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 @Merck read more
Interim Results from Phase 1b/2 Study Evaluating the Combination of Mercks KEYTRUDA (pembrolizumab) and Eisais HALAVEN (eribulin mesylate) Injection in Metastatic Triple-Negative Breast Cancer Presented at 2016 SABCS
2016-12-12 13:00:00| Merck.com - Product News
Dateline City: KENILWORTH, N.J. & WOODCLIFF LAKE, N.J. KENILWORTH, N.J. & WOODCLIFF LAKE, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, and Eisai Inc. today announced new interim data investigating Mercks anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in combination with Eisais microtubule dynamics inhibitor, HALAVEN (eribulin), in patients with metastatic triple-negative breast cancer (TNBC). Language: English Contact: Media:MerckPamela Eisele, 267-305-3558orKim Hamilton, (908) 740-1863orEisai Inc.Laurie Landau, 201-746-2510orInvestors:MerckTeri Loxam, 908-740-1986orAmy Klug, 908-740-1898orEisai Inc.Ivor Macleod, 201-746-2660 Ticker Slug: Ticker: MRK Exchange: NYSE @Merck read more
Tags: results
study
presented
combination
FDA Grants Priority Review to Supplemental Biologics License Application (sBLA) for Mercks KEYTRUDA (pembrolizumab) in Relapsed or Refractory Classical Hodgkin Lymphoma
2016-12-01 13:00:00| 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 accepted for review the supplemental Biologics License Application (sBLA) for KEYTRUDA (pembrolizumab), the companys anti-PD-1 therapy, for the treatment of patients with refractory classical Hodgkin lymphoma (cHL) or for patients who have relapsed after three or more prior lines of therapy. Language: English Contact: MerckMedia:Pamela Eisele, 267-305-3558orKim Hamilton, 908-740-1863orInvestors:Teri Loxam, 908-740-1986orAmy Klug, 908-740-1898 Ticker Slug: Ticker: MRK Exchange: NYSE read more
Tags: review
application
license
classical
FDA Grants Priority Review to Mercks Supplemental Biologics License Application (sBLA) Seeking Approval for KEYTRUDA (pembrolizumab) for New Indication in Microsatellite Instability-High Cancer
2016-11-28 13:00:00| 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) accepted for review the supplemental Biologics License Application (sBLA) for KEYTRUDA (pembrolizumab), the companys anti-PD-1 therapy, for the treatment of previously treated patients with advanced microsatellite instability-high (MSI-H) cancer. Language: English Contact: MerckMedia:Pamela Eisele, 267-305-3558orKim Hamilton, 908-740-1863orInvestors:Teri Loxam, 908-740-1986orAmy Klug, 908-740-1898 Ticker Slug: Ticker: MRK Exchange: NYSE read more
Tags: review
application
license
approval