Oncology

Pivotal Study Demonstrated a Clinically Meaningful Overall Response Rate with Belantamab Mafodotin in Multiple Myeloma

GlaxoSmithKline today announced treatment with the investigational single-agent belantamab mafodotin resulted in a clinically meaningful 31% overall response rate (ORR) with the 2.5 mg/kg regimen in patients with heavily pre-treated multiple myeloma. Patients in the trial received a median of seven prior lines of treatment, were refractory to an immunomodulatory …

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Deciphera Submits Ripretinib NDA to the FDA for Treatment of Patients with Advanced Gastrointestinal Stromal Tumors

WALTHAM, Mass.–(BUSINESS WIRE)–Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH) today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ripretinib, the Company’s investigational broad-spectrum KIT and PDGFRα inhibitor, for the treatment of patients with advanced GIST who have received prior treatment with imatinib, sunitinib …

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Organovo and Tarveda Therapeutics Announce Definitive Merger Agreement

SAN DIEGO & WATERTOWN, Mass.–(BUSINESS WIRE)–Organovo Holdings, Inc. (“Organovo”) (Nasdaq: ONVO) and Tarveda Therapeutics, Inc. (“Tarveda”), a privately-held, clinical stage biopharmaceutical company developing a new class of potent and selective precision oncology medicines, which it refers to as Pentarin miniature drug conjugates, today announced that they have entered into a definitive merger …

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FDA Grants Breakthrough Therapy Designation to Janssen’s BCMA CAR-T Therapy for the Treatment of Relapsed or Refractory Multiple Myeloma

RARITAN, N.J., Dec. 6, 2019 — The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for JNJ-68284528 (JNJ-4528), an investigational B cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (CAR-T) therapy in previously treated patients with multiple myeloma. Breakthrough …

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Bristol-Myers Squibb and bluebird bio Announce Positive Top-line Results from Phase 2 Study of Ide-cel in Relapsed and Refractory Multiple Myeloma

PRINCETON, N.J. & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE: BMY) and bluebird bio, Inc. (Nasdaq: BLUE) today announced positive top-line results from KarMMa, a pivotal, open-label, single arm, multicenter, Phase 2 study of idecabtagene vicleucel (ide-cel; bb2121). KarMMa, which evaluated the efficacy and safety of the companies’ lead investigational BCMA-targeted chimeric antigen …

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ImmunityBio Granted FDA Breakthrough Therapy Designation for N-803 IL-15 Superagonist in Non-Muscle Invasive Bladder Cancer

CULVER CITY, Calif.–(BUSINESS WIRE)–ImmunityBio, a privately held immunotherapy company, has received Breakthrough Therapy Designation (BTD) from the U.S. Food and Drug Administration (FDA) for its interleukin-15 (IL-15) agonist complex, N-803, in combination with Bacillus Calmette-Guerin (BCG), for the treatment of patients with BCG-unresponsive non-muscle invasive bladder carcinoma in situ (CIS). This grant …

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Foundation Medicine Expands Indication for FoundationOne CDx as a Companion Diagnostic for Piqray

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Foundation Medicine, Inc. today announced it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne®CDx to be used as a companion diagnostic for Piqray® (alpelisib) in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor …

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FDA Grants Breakthrough Therapy Designation to Bristol-Myers Squibb’s Orencia to Help Prevent Acute Graft-Versus-Host Disease

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for ORENCIA® (abatacept) for the prevention of moderate to severe acute graft-versus-host disease (GvHD) in hematopoietic stem cell transplants from unrelated donors. There are no approved therapies for the prevention of …

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Omeros Reports Positive Data Across Primary and Secondary Endpoints in Pivotal Trial of HSCT-Associated Thrombotic Microangiopathy Patients Treated with Narsoplimab

SEATTLE–(BUSINESS WIRE)–Omeros Corporation (Nasdaq: OMER) today announced positive data from its pivotal clinical trial of the company’s novel investigational complement inhibitor narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA), a frequently lethal complication of HSCT. These preliminary data were recently provided to FDA as part of …

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FDA Approves Genentech’s Tecentriq Plus Chemotherapy for Initial Treatment of Metastatic Non-Squamous Non-Small Cell Lung Cancer

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) approved Tecentriq® (atezolizumab) in combination with chemotherapy (Abraxane® [paclitaxel protein-bound; nab-paclitaxel] and carboplatin) for the initial (first-line) treatment of adults with metastatic non-squamous non-small cell lung cancer …

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