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Oncology

FDA Approves Herceptin Hylecta for Subcutaneous Injection in Certain HER2-Positive Breast Cancers

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced the U.S. Food and Drug Administration (FDA) has approved Herceptin Hylecta™ (trastuzumab and hyaluronidase-oysk) for subcutaneous (under the skin) injection for the treatment of certain people with HER2-positive early breast cancer (node-positive, …

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TG Therapeutics Announces Positive Outcome from Phase 2b Pivotal Trial Evaluating Umbralisib in Patients with Relapsed/Refractory Marginal Zone Lymphoma

NEW YORK, Feb. 28, 2019 (GLOBE NEWSWIRE) — TG Therapeutics, Inc. (NASDAQ: TGTX), a biopharmaceutical company developing medicines for patients with B-cell mediated diseases, today announced that the Marginal Zone Lymphoma (MZL) cohort of the UNITY-NHL Phase 2b pivotal trial evaluating umbralisib (TGR-1202), our novel, once daily, PI3K delta inhibitor, met …

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Myriad’s BRACAnalysis CDx Test Successfully Identified Patients with Metastatic Pancreatic Cancer Who Benefited from Treatment with Olaparib

SALT LAKE CITY, Feb. 26, 2019 (GLOBE NEWSWIRE) — Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in personalized medicine, today announced that the Phase III POLO study demonstrated its BRACAnalysis CDx®  test successfully identified patients with metastatic pancreatic cancer who have BRCA mutations and benefitted from treatment with olaparib, a novel PARP inhibitor.  Myriad …

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Lynparza Reduced the Risk of Disease Progression or Death as First-Line Maintenance Treatment in BRCA-Mutated Metastatic Pancreatic Cancer

WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca and Merck & Co., Inc., Kenilworth, N.J., US (Merck: known as MSD outside the US and Canada) today announced positive results from the Phase III POLO trial. Results from the trial showed a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS) with LYNPARZA versus placebo. The safety …

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FDA Approves Taiho Oncology’s Lonsurf for Patients with Previously Treated Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

PRINCETON, N.J., February 25, 2019 – Taiho Oncology, Inc. today announced that the United States Food and Drug Administration (FDA) has approved LONSURF® as a treatment for adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, …

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Genmab Announces Positive Topline Results in Phase III Study of Subcutaneous Daratumumab in Multiple Myeloma

Copenhagen, Denmark; February 25, 2019 – Genmab A/S (Nasdaq Copenhagen: GEN) announced today topline results from the Phase III COLUMBA study (MMY3012) of subcutaneous (SC) versus intravenous (IV) daratumumab for patients with relapsed or refractory multiple myeloma. The results showed that SC administration of daratumumab co-formulated with recombinant human hyaluronidase PH20 is …

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Immunomedics Announces Publication of Triple-Negative Breast Cancer Data With Sacituzumab Govitecan in the New England Journal of Medicine

MORRIS PLAINS, N.J., Feb. 20, 2019 (GLOBE NEWSWIRE) — Immunomedics, Inc., (NASDAQ: IMMU) (“Immunomedics” or the “Company”), a leading biopharmaceutical company in the area of antibody-drug conjugates (ADC), today announced that updated data from the Phase 2 study of sacituzumab govitecan in patients with metastatic triple-negative breast cancer (mTNBC) were published on NEJM.org as part …

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FDA Grants Priority Review to Merck’s sBLA for Keytruda Monotherapy for Third-Line Treatment of Patients with Advanced SCLC

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) for KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the treatment of patients with …

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Xencor Announces Partial Clinical Hold on Phase 1 Study of its Bispecific Antibody in Acute Myeloid Leukemia

MONROVIA, Calif., Feb. 20, 2019 /PRNewswire/ — Xencor, Inc. (NASDAQ: XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of cancer, autoimmune diseases, asthma and allergic diseases, today announced that the U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on its Phase 1 study of XmAb14045, a CD123 x …

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Merck’s Keytruda Fails to Meet Primary Endpoints in Phase 3 Study in Patients with Advanced Hepatocellular Carcinoma

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the pivotal Phase 3 KEYNOTE-240 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, plus best supportive care, for the treatment of patients with advanced hepatocellular carcinoma (HCC) who were previously treated with systemic therapy, did …

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