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Oncology

FDA Advisory Committee Votes Against Approval of Daiichi-Sankyo’s Quizartinib for Treatment of Patients with FLT3-ITD Acute Myeloid Leukemia

Tokyo and Basking Ridge, NJ – (May 14, 2019) – Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced the outcome of the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) to discuss the company’s New Drug Application (NDA) for quizartinib for the treatment of adults with relapsed/refractory FLT3-ITD acute …

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Zymeworks Enters its First ZymeLink Antibody-Drug Conjugate Platform Licensing Agreement with Iconic Therapeutics

VANCOUVER, British Columbia–(BUSINESS WIRE)–Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, today announced that it has entered into a licensing agreement that grants Iconic Therapeutics, Inc. (Iconic) non-exclusive rights to Zymeworks’ proprietary ZymeLink™ antibody-drug conjugate (ADC) platform for the development of its ICON-2 Tissue Factor ADC for …

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Lilly’s Cyramza Becomes First FDA-Approved Biomarker-Driven Therapy in Patients with Hepatocellular Carcinoma

INDIANAPOLIS, May 13, 2019 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) has approved CYRAMZA® (ramucirumab injection, 10 mg/mL solution), as a single agent, for the treatment of patients with hepatocellular carcinoma (HCC) who have an alpha-fetoprotein (AFP) of ≥400 ng/mL and have been treated with sorafenib. …

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Celgene’s Pomalyst Granted Breakthrough Therapy Designation from the FDA for HIV-Positive and Negative Kaposi Sarcoma

SUMMIT, N.J.–(BUSINESS WIRE)–Celgene Corporation (NASDAQ:CELG) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to POMALYST® (pomalidomide) for the treatment of patients with human immunodeficiency virus (HIV)-positive Kaposi sarcoma who have previously received systemic chemotherapy, as well as patients with HIV‐negative Kaposi’s sarcoma. Kaposi …

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FDA Grants Orphan Drug Designation to Poseida’s P-BCMA-101 for the Treatment of Multiple Myeloma

SAN DIEGO, May 13, 2019 (GLOBE NEWSWIRE) — Poseida Therapeutics Inc., a clinical-stage biopharmaceutical company leveraging proprietary non-viral gene engineering technologies to create life-saving therapeutics, today announced the United States Food and Drug Administration (FDA) has granted orphan drug designation to P-BCMA-101 for the treatment of relapsed and/or refractory multiple …

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Bristol-Myers’ Opdivo Fails to Meet Primary Endpoint in Phase 3 Study in Patients with Newly Diagnosed MGMT-Unmethylated Glioblastoma Multiforme

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE: BMY) today announced the Phase 3 CheckMate -498 trial evaluating Opdivo (nivolumab) plus radiation versus temozolomide plus radiation in patients with newly diagnosed O6-methylguanine-DNA methyltransferase (MGMT)-unmethylated glioblastoma multiforme (GBM) did not meet its primary endpoint of overall survival (OS) at final analysis. The safety profile of Opdivo was consistent …

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AstraZeneca and Daiich’s HER2 ADC Candidate Meets Primary Endpoint in Pivotal Phase 2 Trial in Breast Cancer

TOKYO and MUNICH and BASKING RIDGE, N.J., May 8, 2019 /PRNewswire/ — Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and AstraZeneca today announced positive topline results for the pivotal phase 2 DESTINY-Breast01 trial of [fam-] trastuzumab deruxtecan (DS-8201). The HER2 targeting antibody drug conjugate (ADC) was evaluated in patients with …

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Sensei Biotherapeutics and AstraZeneca Enter Clinical Trial Collaboration Evaluating the Combination of SNS-301 and Imfinzi

GAITHERSBURG, Md.–(BUSINESS WIRE)–Sensei Biotherapeutics, Inc., a clinical-stage biopharmaceutical company developing precision immuno-oncology therapies, today announced a clinical trial collaboration with AstraZeneca to evaluate the safety, tolerability and preliminary activity of AstraZeneca’s IMFINZI® (durvalumab), a human monoclonal antibody directed against programmed death-ligand 1 (PD-L1), in combination with SNS-301. SNS-301, Sensei’s first-in-class …

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Signatera Blood Tests Detects Bladder Cancer Relapse Up to Eight Months Earlier Than Current Clinical Standards

SAN CARLOS, Calif., May 7, 2019 /PRNewswire/ — Natera, Inc. (NASDAQ: NTRA) today announced the publication of a clinical validation study demonstrating that its Signatera™ molecular residual disease (MRD) test was highly prognostic of recurrence in patients with bladder cancer, and it identified recurrence up to 8.2 months earlier than …

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FDA Grants Breakthrough Device Designation to Natera’s Signatera Test

SAN CARLOS, Calif., May 6, 2019 /PRNewswire/ — Natera, Inc. (NASDAQ: NTRA) today announced that the U.S. Food and Drug Administration (FDA) has granted “Breakthrough Device” designation for its Signatera™ test for use in the post-surgical detection and quantification of circulating tumor DNA (ctDNA) in the blood of patients previously …

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