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 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 …
Tag Archives: HCC
November, 2018
August, 2018
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17 August
FDA Approves Lenvima Capsules for First-Line Treatment of Unresectable Hepatocellular Carcinoma
TOKYO August 17, 2018 – Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Merck & Co., Inc., Kenilworth N.J., U.S.A., known as MSD outside of the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) approved the kinase inhibitor LENVIMA® (lenvatinib mesylate) for the …
July, 2018
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18 July
FDA Grants Breakthrough Therapy Designation to Genentech’s Tecentriq in Combination with Avastin as First-Line Therapy for Advanced HCC
SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for TECENTRIQ®(atezolizumab) in combination with Avastin® (bevacizumab) as an initial (first-line) treatment for people with advanced or metastatic hepatocellular carcinoma …
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11 July
FDA Grants Priority Review to Merck’s sBLA for Keytruda for Treatment of Advanced 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 accepted and granted priority review for a new supplemental Biologics License Application (sBLA) seeking approval for KEYTRUDA, Merck’s anti-PD-1 therapy, as a treatment for previously treated …
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5 July
Exelixis’ Cabozantinib Significantly Improves Overall Survival in Late-Stage Hepatocellular Carcinoma Trial
SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Jul. 4, 2018– Exelixis, Inc. (Nasdaq: EXEL) today announced that The New England Journal of Medicine (NEJM) published results from the CELESTIAL phase 3 pivotal trial of cabozantinib in patients with previously treated advanced hepatocellular carcinoma (HCC).1 The data, originally presented at the 2018 American Society of Clinical Oncology’s Gastrointestinal Cancers …
June, 2018
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6 June
Researchers Identify Blood-Based DNA Biomarker Panel to Accurately Diagnose Hepatocellular Carcinoma
WASHINGTON, June 5, 2018 /PRNewswire/ — Researchers at Exact Sciences Corp. (Nasdaq: EXAS) and Mayo Clinic announced significant progress toward developing a panel of novel, blood-based, DNA biomarkers that could accurately detect hepatocellular carcinoma (HCC), the most common cancer that originates in the liver.1 The researchers detailed their findings during …
May, 2018
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31 May
FDA Accepts Exelixis’ sNDA for Cabometyx in Previously Treated Advanced Hepatocellular Carcinoma
SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Exelixis, Inc. (Nasdaq:EXEL) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the company’s supplemental New Drug Application (sNDA) for CABOMETYX® (cabozantinib) tablets as a treatment for patients with previously treated advanced hepatocellular carcinoma (HCC). The FDA has completed its filing review …
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25 May
FDA Extends Action Date for Eisai and Merck’s sNDA for Lenvima as a First-Line Treatment of Patients with Liver Cancer
WOODCLIFF LAKE, N.J. and KENILWORTH, N.J., May 24, 2018 /PRNewswire/ — Eisai Inc. and Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has extended the action date for the supplemental New Drug Application (sNDA) for lenvatinib …
April, 2018
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5 April
Lilly’s Cyramza Meets Overall Survival Endpoint in Late-Stage Study in Patients with Hepatocellular Carcinoma
INDIANAPOLIS, April 4, 2018 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) today announced top-line results from its Phase 3 REACH-2 study of CYRAMZA® (ramucirumab) as a single agent in the second-line treatment of people with hepatocellular carcinoma (HCC), also known as liver cancer. The trial met its primary endpoint of overall survival (OS) as …
January, 2018
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19 January
Merck to Present First-Time Data for Keytruda in Patients with Previously Treated Advanced Liver Cancer
KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced findings from the registrational phase 2 KEYNOTE-224 trial investigating the use of KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, in patients with advanced hepatocellular carcinoma (HCC), the most common type of liver cancer, who were previously treated …