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Blueprint Medicines Submits NDA to the FDA for Avapritinib for the Treatment of PDGFRA Exon 18 Mutant GIST and Fourth-Line GIST

CAMBRIDGE, Mass., June 14, 2019 /PRNewswire/ — Blueprint Medicines Corporation (NASDAQ: BPMC), a precision therapy company focused on genomically defined cancers, rare diseases and cancer immunotherapy, today announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for avapritinib for the treatment of …

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Bristol-Myers Squibb Announces Empliciti-Based Combination Showed Improvements Across All Efficacy Endpoints in Phase 2 Trial in Multiple Myeloma

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE: BMY) today announced the presentation of updated data from ELOQUENT-3, the international randomized Phase 2 study evaluating Empliciti  (elotuzumab) plus pomalidomide and dexamethasone (EPd) versus pomalidomide and dexamethasone (Pd) alone in patients with relapsed or refractory multiple myeloma (RRMM). In a non-prespecified analysis conducted …

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FDA Approves Amgen and Allergan’s Kanjinti, a Biosimilar to Herceptin

THOUSAND OAKS, Calif., June 13, 2019 /PRNewswire/ — Amgen (NASDAQ:AMGN) and Allergan plc (NYSE:AGN) today announced that the U.S. Food and Drug Administration (FDA) has approved KANJINTI™ (trastuzumab-anns) for all approved indications of the reference product, Herceptin® (trastuzumab):  for the treatment of HER2-overexpressing adjuvant and metastatic breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. “The FDA approval of KANJINTI is …

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New Results from Phase 2 Trial Demonstrate Potential Clinical Benefit of IMV’s DPX-Survivac in Combination with Merck’s Keytruda in DLBCL Patients

DARTMOUTH, Nova Scotia–(BUSINESS WIRE)–IMV Inc. (Nasdaq:IMV; TSX:IMV), a clinical stage immuno-oncology corporation, today announced updated data from the ongoing investigator-sponsored SPiReL Phase 2 clinical trial assessing IMV’s lead candidate, DPX-Survivac, in combination with intermittent low dose cyclophosphamide and Merck’s checkpoint inhibitor Keytruda® (pembrolizumab). The trial is designed to evaluate the …

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Boehringer Ingelheim and University of Dundee Highlight Successful PROTAC Drug Discovery Program and Extend Their Ongoing Anti-Cancer Alliance

Ingelheim, Germany and Dundee, United Kingdom, 11 June, 2019 – Following the success of their ongoing alliance, Boehringer Ingelheim and the University of Dundee extend their collaboration to develop new medicines that target and destroy key cancer causing proteins. This brings together the expertise of Professor Alessio Ciulli, one of the …

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Ziopharm Oncology Announces FDA Clearance of IND for Sleeping Beauty TCR-T Cell Therapy Trial at NCI

BOSTON, June 11, 2019 (GLOBE NEWSWIRE) — Ziopharm Oncology, Inc. (“Ziopharm” or “the Company”) (Nasdaq:ZIOP) announced that the investigational new drug (IND) application submitted by the National Cancer Institute (NCI) has received clearance from the U.S. Food and Drug Administration (FDA) for a clinical trial in solid tumors to evaluate T-cell …

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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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