Specialty Pharma Journal Specialty, Precision & Technology
Mutations in RAS proteins initiate many of the most aggressive tumors, and the search for pharmacological inhibitors of these proteins has become a priority in the battle against cancer. Michail Steklov, Francesca Baietti, and colleagues from the Anna Sablina lab (VIB-KU Leuven Center for Cancer Biology) identified LZTR1 as an …
Tag Archives: liver cancer
November, 2018
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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 …
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 …
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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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 …
October, 2017
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18 October
Ipsen and Exelixis’ Cabozantinib Meets Primary Endpoint in Phase 3 Hepatocellular Carcinoma Trial
PARIS–(BUSINESS WIRE)–Regulatory News: Ipsen (Euronext: IPN; ADR: IPSEY) and its partner Exelixis (NASDAQ: EXEL) today announced that its global phase 3 CELESTIAL trial met its primary endpoint of overall survival (OS), with cabozantinib providing a statistically significant and clinically meaningful improvement in median OS compared to placebo in patients with …