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FDA Expands Approval of Merck’s Keytruda for Two New Indications

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, as monotherapy in patients whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1) or in combination with platinum and fluorouracil …

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Genmab Signs Agreement with Janssen for Next-Generation CD38 Antibody, HexaBody-CD38

Copenhagen, Denmark; June 11, 2019 – Genmab A/S (Nasdaq Copenhagen: GEN) announced today it has entered into an exclusive worldwide license and option agreement with Janssen Biotech, Inc. (Janssen) to develop and commercialize HexaBody-CD38, a next-generation human CD38 monoclonal antibody product incorporating Genmab’s proprietary HexaBody technology. Under the terms of the …

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Veracyte Announces New Publication of Data Demonstrating Real-World Performance of the Afirma GSC in Thyroid Cancer Diagnosis

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Veracyte, Inc. (Nasdaq: VCYT) announced today that findings from a new real-world study show that the company’s Afirma® Genomic Sequencing Classifier (GSC) helps to identify significantly more benign thyroid nodules and further reduce unnecessary surgeries in thyroid cancer diagnosis, as compared to the original Afirma test. Findings …

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FDA Grants Accelerated Approval of Genentech’s Polivy for Treatment of Patients with Previously Treated Aggressive Lymphoma

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 accelerated approval to Polivy™ (polatuzumab vedotin-piiq) in combination with bendamustine plus Rituxan® (rituximab) (BR) for the treatment of adults with relapsed or refractory …

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Merck to Acquire Tilos Pharmaceuticals for up to $773 Million, Gaining Portfolio of Investigational Antibodies Modulating TGFβ

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that it has entered into a definitive agreement to acquire Tilos Therapeutics, a privately held biopharmaceutical company developing therapeutics targeting the latent TGFβ complex for the treatment of cancer, fibrosis and autoimmune diseases. “At …

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Deciphera Expands Pipeline with Potential First-in-Class Autophagy Inhibitor to Treat Mutant RAS Cancers

WALTHAM, Mass.–(BUSINESS WIRE)–Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH) today announced the addition of a new candidate to its pipeline, DCC-3116, a potential first-in-class small molecule designed to inhibit cancer autophagy, a key tumor survival mechanism. DCC-3116, discovered using the Company’s novel switch control inhibitor platform, is designed to inhibit autophagy by inhibiting …

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CStone and Bayer Partner to Evaluate PD-L1 Monoclonal Antibody CS1001 in Combination with Regorafenib

SUZHOU, China, June 9, 2019 /PRNewswire/ — CStone Pharmaceuticals (“CStone”; HKEX: 2616) today announced that the company has entered into a global clinical collaboration with China focus with Bayer HealthCare LLC to evaluate the safety, tolerability, pharmacokinetics (PK) and antitumor activity of its PD-L1 monoclonal antibody CS1001 in combination with …

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Taiho Oncology Enters Agreement with Otsuka to Commercialize Astex Pharmaceuticals’ Drug Candidates

PRINCETON, N.J., June 7, 2019 /PRNewswire/ — Taiho Oncology, Inc. announces that it has assumed commercialization responsibility from Otsuka Pharmaceuticals Co., Ltd., (Otsuka) for the novel fixed-dose combination of cedazuridine and decitabine (ASTX727) and guadecitabine (SGI-110) in the U.S. and Canada, subject to regulatory approvals. Taiho Pharma Canada, Inc., will …

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Novel Oral Cedazuridine/Decitabine Fixed-Dose Combination Meets Primary Endpoint in Phase 3 Study in Patients with Myelodysplastic Syndromes or Chronic Myelomonocytic Leukemia

PLEASANTON, Calif. & TOKYO–(BUSINESS WIRE)–Astex Pharmaceuticals, Inc. a member of the Otsuka group of companies, and Otsuka Pharmaceutical Co. Ltd., announce top-line results from the ASCERTAIN phase 3 study evaluating cedazuridine and decitabine fixed-dose combination (ASTX727) vs decitabine IV in adults with intermediate and high-risk MDS or CMML. The study …

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New Data on Vitrakvi in TRK Fusion Cancer Patients with Brain Metastases or Primary Central Nervous System Tumors

WHIPPANY, N.J., June 3, 2019 /PRNewswire/ — Bayer today announced results of a new analysis from clinical trials investigating Vitrakvi® (larotrectinib) in patients with TRK fusion cancer with primary central nervous system (CNS) tumors or brain metastases. The analysis included 14 patients with primary CNS tumors evaluable for efficacy, including …

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