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Merck Receives FDA Acceptance of Supplemental Biologics License Application for KEYTRUDA (pembrolizumab) in Combination with Chemotherapy for First-Line Treatment of Metastatic Non-Squamous Non-Small Cell Lung Cancer

2017-01-10 22:06:00| Merck.com - Product News

Dateline City: KENILWORTH, N.J. Submission Based on Data from KEYNOTE-021 Trial, Cohort G, Which 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 that the U.S. Language: English Contact: MerckMedia:Pamela Eisele, 267-305-3558orCourtney Ronaldo, 908-236-1108orInvestor:Teri Loxam, 908-740-1986orAmy Klug, 908-740-1898 Ticker Slug: Ticker: MRK Exchange: NYSE @Merck read more

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KEYTRUDA (pembrolizumab) Approved as First Anti-PD-1 Therapy in Japan for First-Line Treatment of Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) Whose Tumors Express High Levels of PD-L1

2016-12-19 13:00:00| Merck.com - Product News

Dateline City: KENILWORTH, N.J. KEYTRUDA Also Approved for Second-Line Treatment of Patients with Advanced NSCLC Whose Tumors Express PD-L1 KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that KEYTRUDA (pembrolizumab), the companys anti-PD-1 therapy, has been approved in Japan for the treatment of certain patients with PD-L1-positive unresectable advanced/recurrent non-small cell lung cancer (NSCLC) in the first- and second-line treatment settings at a fixed dose of 200 mg every three weeks. MSD will manufacture and market KEYTRUDA in Japan and will promote it with Taiho Pharmaceutical Co., Ltd. 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

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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

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KEYTRUDA (pembrolizumab) Demonstrated Improved Health-Related Quality of Life Compared to Chemotherapy in First-Line Treatment of Patients with Metastatic Non-Small Cell Lung Cancer (NSCLC)

2016-12-07 08:45:00| Merck.com - Product News

Dateline City: KENILWORTH, N.J. First Presentation of Patient-Reported Outcomes from KEYNOTE-024 Study of Patients with Metastatic NSCLC Whose Tumors Have High PD-L1 Expression (Tumor Proportion Score [TPS] of 50 Percent or More) Findings Presented in Plenary Session at 17 th World Conference on Lung Cancer KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced positive health-related quality of life (HRQoL) findings from an exploratory analysis from the phase 3 KEYNOTE-024 study investigating the use of KEYTRUDA (pembrolizumab), the companys anti-PD-1 therapy, compared to standard of care (SOC) platinum-containing chemotherapy for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express high levels of PD-L1 (tumor proportion score [TPS] of 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

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KEYTRUDA (pembrolizumab) Treatment Results in Patients with Relapsed or Refractory Classical Hodgkin Lymphoma (cHL) Presented at 58th Annual Meeting of the American Society of Hematology

2016-12-06 01:30:00| Merck.com - Product News

Dateline City: KENILWORTH, N.J. Data from Pivotal KEYNOTE-087 Trial Show Overall Response Rate (ORR) of 69.0 Percent and Complete Remission Rate (CRR) of 22.4 Percent With More than Two Years of Follow-up, Findings from KEYNOTE-013 Show ORR of 58 Percent and CRR of 19 Percent with Responses of 12 Months or Greater in 70 Percent of Responding Patients KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today updated findings evaluating KEYTRUDA (pembrolizumab), the companys anti-PD-1 therapy, in two trials of patients with relapsed or refractory classical Hodgkin lymphoma (cHL). In the KEYNOTE-087 and KEYNOTE-013 trials, KEYTRUDA demonstrated overall response rates (ORR) of 69.0 percent and 58 percent, respectively. 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 @Merck read more

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