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Oncology

NANOBIOTIX Announces Positive Phase II/III Topline Data of Investigational NBTXR3 in Soft Tissue Sarcoma

Paris, France and Cambridge, Massachusetts, June 21, 2018 – NANOBIOTIX (Euronext: NANO – ISIN: FR0011341205), a late clinical-stage nanomedicine company pioneering new approaches in the treatment of cancer, announced today positive topline results of the Phase II/III act.in.sarc trial evaluating NBTXR3 in Soft Tissue Sarcoma (STS). “Data are exceptional and show without any …

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FDA Accepts sNDA for Opdivo Plus Low-Dose Yervoy for Treatment of First-Line NSCLC in Patients with Tumor Mutational Burden ≥10 mut/Mb

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE: BMY) announced today that the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) plus low-dose Yervoy (ipilimumab) for the treatment of first-line advanced non-small cell lung cancer (NSCLC) in patients with tumor mutational burden (TMB) ≥10 mutations per megabase (mut/Mb). …

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Servier and Taiho Announce Lonsurf Demonstrates Significant Overall Survival Benefit in Phase 3 Gastric Cancer Trial

PARIS–(BUSINESS WIRE)–Servier and Taiho Pharmaceutical Co., Ltd. today announced clinical data from the pivotal Phase III trial (TAGS) for LONSURF® (trifluridine and tipiracil, TAS-102) which showed significant improvement in overall survival (OS) for the treatment of patients with refractory metastatic gastric cancer (HR=0.69 [95% IC 0.56-0.85], p=0.0003). The median overall survival …

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TG and Novimmune Collaborate for Development of CD47-CD19 Bispecific Antibody

NEW YORK, June 20, 2018 (GLOBE NEWSWIRE) — TG Therapeutics, Inc. (NASDAQ:TGTX) and Novimmune SA, today announced that the companies have entered into an exclusive global agreement to collaborate on the development and commercialization of Novimmune’s novel first-in-class anti-CD47/anti-CD19 bispecific antibody known as TG-1801 (previously NI-1701). The companies will jointly develop …

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Published Case Report Demonstrates the Clinical Utility of Biocept’s CTC Platform in Metastatic Breast Cancer

SAN DIEGO, June 18, 2018 /PRNewswire/ — Biocept, Inc. (NASDAQ: BIOC), a leading commercial provider of liquid biopsy tests designed to provide physicians with clinically actionable information to improve the outcomes of patients diagnosed with cancer, announces the publication of a peer-reviewed case report demonstrating the clinical utility of its …

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FDA Grants Fast Track Status to ImmunoGen’s Mirvetuximab Soravtansine in Platinum-Resistant Ovarian Cancer

WALTHAM, Mass.–(BUSINESS WIRE)–ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its lead program, mirvetuximab soravtansine. The designation is for the treatment of patients with …

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Celltrion Completes Resubmission to FDA for CT-P6, a Proposed Trastuzumab Biosimilar

INCHEON, South Korea–(BUSINESS WIRE)–Celltrion (KRX:068270) has made a resubmission to the FDA (U.S. Food and Drug Administration) to obtain its marketing approval for CT-P6, a proposed mAb biosimilar to Herceptin® (trastuzumab). Celltrion submitted its abbreviated Biologics License Applications (aBLAs) for CT-P10 and CT-P6 to the FDA in April and May of last …

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Epliciti Plus Pomalidomide and Low-Dose Dexamethasone Meets Primary Endpoint of Progression-Free Survival in Multiple Myeloma Trial

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE:BMY) today announced that the ELOQUENT-3 trial, an international Phase 2 study evaluating the addition of Empliciti (elotuzumab) to pomalidomide and low-dose dexamethasone (EPd) in patients with relapsed/refractory multiple myeloma (RRMM), achieved its primary endpoint, showing a statistically significant and clinically meaningful improvement in progression-free survival (PFS) for …

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Pancreatic Cancer Patients with BRCA Mutation may Benefit from Targeted Drug

A physician-scientist at the University of Arizona Cancer Center investigated a novel treatment for pancreatic cancer patients whose tumors exhibited a harmful genetic mutation. The results, in which a type of drug called a PARP inhibitor showed early promise in treating pancreatic cancer in patients with mutations in the BRCA …

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Apexigen and Yale Cancer Center Collaborate to Evaluate APX005M, Cabiralizumab, and Opdivo in Patients whose Disease has Progressed on Anti-PD-1/PD-L1 Therapy

San Carlos, CA, and New Haven, CT – June 14, 2018 – Apexigen, Inc., and Yale Cancer Center today announced a clinical trial collaboration to evaluate Apexigen’s APX005M in combination with cabiralizumab and Opdivo in patients with advanced solid tumors. The Phase 1/2 clinical trial will evaluate the safety, tolerability, and preliminary activity of …

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