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Oncology

FDA Grants Priority Review to Taiho Oncology’s sNDA for Lonsurf for Treatment of GEJ Adenocarcinoma

PRINCETON, N.J., October 25, 2018 – Taiho Oncology, Inc. today announced that the United States Food and Drug Administration (FDA) has accepted and granted priority review for the supplemental New Drug Application (sNDA) for LONSURF® (trifluridine/tipiracil, TAS-102) as a treatment for patients with previously treated, advanced or metastatic gastric adenocarcinoma, including …

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Bayer’s Darolutamide Meets Primary Endpoint in Phase 3 Trial in Patients with Non-Metastatic Castration-Resistant Prostate Cancer

WHIPPANY, N.J., Oct. 24, 2018 /PRNewswire/ — The Phase III ARAMIS (Androgen Receptor inhibiting Agent for MetastatIc-free Survival) trial that investigated darolutamide in men with non-metastatic castration-resistant prostate cancer (nmCRPC), met its primary endpoint. Darolutamide significantly extended metastasis-free survival (MFS) compared to placebo. The safety profile and the tolerability of darolutamide observed in the ARAMIS trial were …

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AstraZeneca Strengthens and Expands Oncology Development and Commercialization Collaboration with Innate Pharma

AstraZeneca, and its global biologics research and development arm MedImmune, today announced a new multi-term agreement with Innate Pharma (Innate), building on an existing collaboration, aimed at accelerating each company’s oncology portfolio and bringing new medicines to patients more quickly. The extended collaboration will enrich AstraZeneca’s immuno-oncology (IO) portfolio with …

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Revlimid Demonstrated a Significant Improvement in Progression-Free Survival Compared with Observation in Patients with Smoldering Multiple Myeloma

SUMMIT, N.J.–(BUSINESS WIRE)–Celgene Corporation (NASDAQ: CELG) today announced results from an open-label phase II/III National Clinical Trials Network (NCTN) study led by the ECOG-ACRIN Cancer Research Group and sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health. REVLIMID® (lenalidomide) was provided by Celgene under a clinical …

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FDA Approves Spectrum Pharmaceuticals’ Khapzory for Injection for Three Indications

HENDERSON, Nev.–(BUSINESS WIRE)–Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced that the U.S. Food and Drug Administration (FDA) has approved KHAPZORY (levoleucovorin) for injection, a folate analog for three indications: • Rescue …

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Genentech’s Tecentriq Plus Chemotherapy as Initial Treatment Helped Advanced Non-Squamous NSCLC Patients Live Significantly Longer than Chemotherapy Alone

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced positive results from the Phase III IMpower130 study of Tecentriq® (atezolizumab) plus chemotherapy (carboplatin and Abraxane® [albumin-bound paclitaxel; nab-paclitaxel]) for the initial (first-line) treatment of people with previously untreated metastatic non-squamous non-small cell lung cancer …

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SELLAS Announces Positive Final Data from Phase 2b Trial of NeuVax in Combination with Herceptin in Triple Negative Breast Cancer

NEW YORK, Oct. 22, 2018 (GLOBE NEWSWIRE) —  SELLAS Life Sciences Group, Inc. (Nasdaq:SLS) (“SELLAS” or the “Company”), a clinical-stage biopharmaceutical company focused on the development of novel cancer immunotherapies for a broad range of cancer indications, today announced data from the prospective, randomized, single-blinded, controlled Phase 2b independent investigator-sponsored …

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Lynparza Maintenance Therapy Cut the Risk of Disease Progression or Death by 70% in BRCA-Mutated Ovarian Cancer in Phase 3 Trial

KENILWORTH, N.J.–(BUSINESS WIRE)–AstraZeneca and Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced detailed results from the Phase 3 SOLO-1 trial testing LYNPARZA 300 mg tablets twice daily as a maintenance treatment for patients with newly-diagnosed advanced BRCA-mutated (BRCAm) ovarian cancer who were in complete or partial …

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Lonsurf Meets Primary and Secondary Endpoints in its Late-Stage Study in Patients with Refractory Metastatic Gastric Cancer

PARIS–(BUSINESS WIRE)–Servier and Taiho Oncology, Inc. (U.S.), a subsidiary of Taiho Pharmaceutical Co., Ltd. (Japan), jointly announced today clinical data from the pivotal Phase III TAS-102 Gastric Study (TAGS) evaluating LONSURF® (trifluridine/tipiracil, TAS-102) versus placebo and best supportive care in patients with heavily pre-treated metastatic gastric cancer who have progressed or …

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Takeda to Present Results from Phase 3 Trial Highlighting Intracranial Efficacy of Alunbrig Versus Crizotinib in First-Line Advanced ALK+ NSCLC

CAMBRIDGE, Mass. & OSAKA, Japan–(BUSINESS WIRE)–Takeda Pharmaceutical Company Limited (TSE: 4502) today announced that intracranial efficacy data from the Phase 3 ALTA-1L (ALK in Lung Cancer Trial of BrigAtinib in 1st Line) trial showed improved intracranial progression-free survival (PFS) and intracranial objective response rate (ORR) with ALUNBRIG (brigatinib) compared to crizotinib among anaplastic lymphoma …

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