Specialty Pharma Journal Specialty, Precision & Technology
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 extended the action date for the supplemental Biologics License Application (sBLA) for KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the first-line treatment of locally advanced …
Tag Archives: Keytruda
December, 2018
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20 December
FDA Approves Merck’s Keytruda for Treatment of Patients with Recurrent Locally Advanced or Metastatic Merkel Cell Carcinoma
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, Merck’s anti-PD-1 therapy, for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC), based on the …
November, 2018
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15 November
Merck’s Keytruda Significantly Improved Overall Survival Compared to Chemotherapy in Certain Patients with Advanced Esophageal or Esophagogastric Junction Carcinoma
KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that the Phase 3 KEYNOTE-181 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy in the second-line treatment of advanced or metastatic esophageal or esophagogastric junction carcinoma has met a primary endpoint of overall survival (OS) …
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9 November
FDA Provides Accelerated Approval to Merck’s Keytruda for Treatment of Patients with Hepatocellular Carcinoma
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, Merck’s anti-PD-1 therapy, for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under …
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9 November
New Data Support Ongoing Clinical Program for Lenvima and Keytruda Combination Across Multiple Tumor Types
TOKYO & KENILWORTH, N.J.–(BUSINESS WIRE)–Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced results from presentations of new data and analyses of LENVIMA® (lenvatinib), an orally available kinase inhibitor discovered by Eisai, in combination with Merck’s anti-PD-1 …
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7 November
OncoSec Reports Preliminary Data from Phase 2b Trial of Tavo in Combination with Keytruda in Patients with Metastatic Melanoma
SAN DIEGO and PENNINGTON, N.J., Nov. 6, 2018 /PRNewswire/ — OncoSec Medical Incorporated (OncoSec) (NASDAQ: ONCS), a company developing novel cancer immunotherapies based on its proprietary technology generating sustained intratumoral IL-12 levels, today reported preliminary data from KEYNOTE-695, a global, multicenter Phase 2b, open-label trial of intratumoral delivery of TAVO™ (tavokinogene telseplasmid / IL-12) with intravenous …
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1 November
FDA Approves Merck’s Keytruda in Combination with Chemotherapy for First-Line Treatment of Metastatic Squamous NSCLC
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, Merck’s anti-PD-1 therapy, in combination with carboplatin and either paclitaxel or nab-paclitaxel, for the first-line treatment of patients with metastatic squamous non-small cell …
October, 2018
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19 October
BioLineRx Presents Top-Line Results from its Mid-Stage Study in Pancreatic Cancer at ESMO
Tel Aviv, Israel, October 19, 2018 – BioLineRx Ltd. (NASDAQ/TASE:BLRX), a clinical-stage biopharmaceutical company focused on oncology and immunology, today announced top-line results from the dual combination arm of the Phase 2a COMBAT/KEYNOTE-202 study, evaluating patients with metastatic pancreatic adenocarcinoma (PDAC) treated with BL-8040 in combination with KEYTRUDA® (pembrolizumab), an …
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18 October
Keytruda in Combination with Inlyta Significantly Improved Overall Survival and Progression-Free Survival in Advanced or Metastatic Renal Cell Carcinoma
KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the pivotal Phase 3 KEYNOTE-426 trial investigating KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with Inlyta® (axitinib), Pfizer’s tyrosine kinase inhibitor, met both primary endpoints of overall survival (OS) and progression-free survival (PFS) in the …
September, 2018
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12 September
FDA Grants Priority Review to Merck’s Application for Keytruda for First-Line Treatment of Locally Advanced or Metastatic NSCLC Tumors Expressing 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 review and granted priority review to a new supplemental Biologics License Application (sBLA) seeking approval for KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for …