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Oncology

FDA Grants Accelerated Approval to Bristol-Myers Squibb’s Opdivo for Treatment of Small Cell Lung Cancer

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE:BMY) today announced that Opdivo (nivolumab) received approval from the U.S. Food and Drug Administration (FDA) as the first and only Immuno-Oncology treatment option for patients with metastatic small cell lung cancer (SCLC) whose cancer has progressed after platinum-based chemotherapy and at least one other line of therapy.1 Approval …

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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 …

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Natera and Fox Chase Cancer Center to Collaborate to Assess the Signatera Customized ctDNA Assay for Monitoring Kidney Cancer

SAN CARLOS, Calif., Aug. 15, 2018 /PRNewswire/ — Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, has partnered with Fox Chase Cancer Center, one of the leading cancer centers in the United States, to assess the company’s Signatera™ (Research-Use Only) customized circulating tumor DNA (ctDNA) assay for …

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RXi Pharmaceuticals Partners with Karolinska Institutet to Develop sd-rxRNA Compounds to Advance Immuno-Oncology Therapeutics

MARLBOROUGH, Mass., Aug. 15, 2018 /PRNewswire/ — RXi Pharmaceuticals Corporation (NASDAQ: RXII) a biotechnology company developing the next generation of immuno-oncology therapeutics based on its proprietary self-delivering RNAi (sd-rxRNA®) therapeutic platform today announced that it has entered into a research collaboration with the Karolinska Institutet in Stockholm, Sweden. This collaboration …

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CEL-SCI Reports Recent Data Review by the IDMC for Its Pivotal Phase 3 Head and Neck Cancer Study

VIENNA, Va.–(BUSINESS WIRE)–CEL-SCI Corporation (NYSE American: CVM) announced today that the Independent Data Monitoring Committee (IDMC) for the Company’s pivotal Phase 3 head and neck cancer study of its investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection) has completed its recent review of the Phase 3 study data. The data from all 928 enrolled …

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Novocure and US Oncology Research Collaborate on PANOVA-3 Trial for Patients with Advanced Pancreatic Cancer

ST. HELIER, Jersey & THE WOODLANDS, Texas–(BUSINESS WIRE)–Novocure (NASDAQ: NVCR) and US Oncology Research are collaborating on PANOVA-3, a phase 3 pivotal trial testing the efficacy of Tumor Treating Fields combined with nab-paclitaxel and gemcitabine in patients with unresectable locally advanced pancreatic cancer. Tumor Treating Fields is a cancer therapy that uses …

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ArQule Announces Publication of Preclinical Data for ARQ 531, a Reversible Inhibitor of Both Wild Type and Mutant BTK

BURLINGTON, Mass.–(BUSINESS WIRE)–ArQule, Inc. (Nasdaq:ARQL), today announced the publication of preclinical study data for ARQ 531, the Company’s rationally-designed, reversible inhibitor of both wild type and C481S-mutant Bruton’s tyrosine kinase (BTK). The studies, published in Cancer Discovery, were conducted in collaboration with researchers at The Ohio State University. Data from …

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Cellectar’s CLR 131 Receives FDA Rare Pediatric Disease Designation for the Treatment of Ewing’s Sarcoma

MADISON, Wis., Aug. 13, 2018 (GLOBE NEWSWIRE) — Cellectar Biosciences (Nasdaq: CLRB), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, announces today that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation (RPDD) to CLR 131, …

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Celltrion Initiates Global Phase 3 Trial for its Bevacizumab Biosimilar CT-P16

INCHEON, South Korea–(BUSINESS WIRE)–Celltrion, Inc. (KRX:068270) is set to launch global Phase 3 clinical trial for its bevacizumab biosimilar ‘CT-P16’ for the treatment of cancer. Celltrion successfully completed Phase 1 clinical study on the safety and pharmacokinetic assessment of CT-P16 in June 2018. Further, it recently submitted its Clinical Trial Application …

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FDA Approves Kyowa Kirin’s Poteligeo for Treatment of Two Rare Types of Non-Hodgkin Lymphoma

TOKYO, Aug. 8, 2018 /PRNewswire/ — Kyowa Hakko Kirin Co., Ltd., (Kyowa Kirin) announces today that the U.S. Food and Drug Administration (FDA) has granted approval for Poteligeo® (mogamulizumab-kpkc) for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one …

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