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FDA Grants Priority Review to GSK’s Belantamab Mafodotin for Treatment of Relapsed or Refractory Multiple Myeloma

GlaxoSmithKline plc (LSE/NYSE: GSK) announced the US Food and Drug Administration (FDA) granted a priority review for the company’s Biologics License Application (BLA) seeking approval of belantamab mafodotin (GSK2857916) for the treatment of patients with relapsed or refractory multiple myeloma whose prior therapy included an immunomodulatory agent, a proteasome inhibitor …

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Genprex Receives Fast Track Designation from the FDA for its Gene Therapy that Targets Lung Cancer

AUSTIN, Texas & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Genprex, Inc. (“Genprex” or the “Company”) (NASDAQ: GNPX), a clinical-stage gene therapy company utilizing a unique, non-viral proprietary platform designed to deliver tumor suppressor genes to cancer cells, today announced that the U.S Food and Drug Administration (FDA) has granted Fast Track Designation for Genprex’s Oncoprex™ immunogene …

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FDA Accepts and Grants Priority Review for Lynparza sNDA in HRR-Mutated Metastatic Castration-Resistant Prostate Cancer

KENILWORTH, N.J.–(BUSINESS WIRE)–AstraZeneca and Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that a supplemental New Drug Application (sNDA) for LYNPARZA has been accepted and granted priority review by the U.S. Food and Drug Administration (FDA) for the treatment of patients with metastatic castration-resistant …

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BeiGene’s Tislelizumab Meets its Primary Endpoint in Interim Analysis of Phase 3 Trial in Patients with First-Line Squamous NSCLC

BEIJING, China, and CAMBRIDGE, Mass., Jan. 21, 2020 (GLOBE NEWSWIRE) — BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, today announced that the pivotal Phase 3 trial evaluating its anti-PD-1 antibody tislelizumab in combination with …

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FDA Grants Orphan Drug Designation to OBI Pharma’s Investigational Gastric Cancer Treatment

TAIPEI, Taiwan, Jan. 21, 2020 /PRNewswire/ — OBI Pharma, Inc., a Taiwan biopharma company (TPEx: 4174), today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for OBI-999 for the treatment of Gastric Cancer. OBI-999 is a first-in-class antibody drug conjugate targeting Globo H, a …

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BerGenBio Meets Efficacy Endpoint for First Stage of Phase II Trial with Bemcentinib in Combination with Keytruda in NSCLC

BERGEN, Norway, Jan. 15, 2020 /PRNewswire/ — BerGenBio ASA (OSE: BGBIO) a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for multiple cancer indications, announces meeting the clinical efficacy endpoint of stage 1 of Cohort B in the phase II trial (BGBC008) evaluating bemcentinib in combination with MSD’s Keytruda® …

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ArcherDX Personalized Cancer Monitoring Technology Designated by FDA as Breakthrough Device

BOULDER, Colo., Jan. 14, 2020 /PRNewswire/ — ArcherDX, Inc., today announced it has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its Personalized Cancer Monitoring (PCM) technology, a bespoke, minimally-invasive and highly-sensitive product intended for early-stage cancer treatment monitoring and recurrence surveillance. ArcherDX’s technology enables …

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QIAGEN Builds on Global Collaboration With Amgen for Companion Diagnostic Development in Non-small Cell Lung Cancer

Hilden, Germany and Germantown, Maryland, January 13, 2020 – QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced a strategic collaboration to develop tissue-based companion diagnostics for Amgen’s investigational cancer treatment AMG 510 to identify patients with cancers that have the KRAS G12C mutation. The agreement focuses initially on companion diagnostics …

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FDA Grants Priority Review to Clovis Oncology’s Rubraca for Treatment of Advanced Prostate Cancer

BOULDER, Colo.–(BUSINESS WIRE)–Clovis Oncology, Inc. (NASDAQ: CLVS) announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental New Drug Application (sNDA) for Rubraca® (rucaparib) and granted priority review status to the application with a Prescription Drug User Fee Act (PDUFA) date of May 15, 2020. Clovis …

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FDA Accepts for Priority Review Bristol-Myers Squibb’s Application for Opdivo Plus Yervoy in First-Line NSCLC

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE: BMY) today announced the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the first-line treatment of patients with metastatic or recurrent non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations. …

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