Oncology

Janssen and GenCentric Enter Research Collaboration on Genomic Drug Response Biomarkers for Non-Muscle Invasive Bladder Cancer

DURHAM, N.C.–(BUSINESS WIRE)–GeneCentric Therapeutics today announced it has entered into a research collaboration with Janssen Research & Development, LLC (Janssen) around RNA-based drug response biomarkers for non-muscle invasive bladder cancer (NMIBC). The research will involve the application of GeneCentric’s advanced RNA-based molecular profiling platform to elucidate potential signatures of disease …

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Phase 3 Trial Evaluating Opdivo as Adjuvant Therapy for Patients with Resected Esophageal or GEJ Cancer Meets Primary Endpoint

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol Myers Squibb (NYSE: BMY) today announced the Phase 3 CheckMate -577 trial evaluating Opdivo (nivolumab) as an adjuvant therapy for patients with resected esophageal or gastroesophageal junction (GEJ) cancer met its primary endpoint of disease-free survival (DFS) at a pre-specified interim analysis. In the trial, treatment with Opdivo following neoadjuvant chemoradiation therapy …

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Mersana Receives FDA Fast Track Designation for XMT-1536 for the Treatment of Patients with Platinum-resistant Ovarian Cancer

CAMBRIDGE, Mass., Aug. 11, 2020 (GLOBE NEWSWIRE) — Mersana Therapeutics, Inc. (NASDAQ:MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track …

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Phase 3 Opdivo Trial Meets Primary Endpoints Demonstrating Superior OS and PFS in First-Line Treatment of Gastric and Esophageal Cancers

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol Myers Squibb (NYSE: BMY) today announced that CheckMate -649, a pivotal Phase 3 trial evaluating Opdivo (nivolumab) plus chemotherapy compared to chemotherapy alone as a first-line treatment for metastatic gastric cancer, gastroesophageal junction (GEJ) cancer or esophageal adenocarcinoma, met both primary endpoints of overall survival (OS) at a pre-specified interim …

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FDA Rejects Fennec’s NDA for Pedmark for Treatment of Ototoxicity Associated with Cisplatin in Pediatric Patients with Solid Tumors

RESEARCH TRIANGLE PARK, N.C., Aug. 11, 2020 (GLOBE NEWSWIRE) — Fennec Pharmaceuticals Inc., a specialty pharmaceutical company, today announced that it received a Complete Response Letter (CRL) on August 10, 2020 from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for PEDMARK™ (a unique formulation of sodium …

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Verastem Oncology to Sell Copiktra Rights to Secura Bio to Focus on Development of VS-6766 and Defactinib in KRAS Mutant Solid Tumors

BOSTON–(BUSINESS WIRE)–Verastem, Inc. (Nasdaq:VSTM) (also known as Verastem Oncology), a biopharmaceutical company committed to advancing new medicines for patients battling cancer, today announced that it has entered into a definitive agreement to sell its global commercial and development rights to COPIKTRA (duvelisib), its marketed oral inhibitor of phosphoinositide 3-kinase (PI3K), …

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Additional Analysis of Real-World Data Confirms Sequential Gilotrif Followed by Osimertinib Provided a Median OS of Nearly 4 Years in US Patients with EGFR+ NSCLC

Ridgefield, Conn., August, 10, 2020 – Boehringer Ingelheim today announced a new analysis from the GioTag study, which showed that sequential Gilotrif® (afatinib) and osimertinib contributed to a median overall survival (OS) of nearly four years (47.6 months) among U.S. patients (129) with epidermal growth factor receptor mutation-positive (EGFR M+) non-small cell …

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Opdivo Plus Yervoy Demonstrates Durable Survival Benefit vs. Chemotherapy in Previously Untreated Malignant Pleural Mesothelioma

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol Myers Squibb (NYSE: BMY) today announced that Opdivo® (nivolumab) plus Yervoy® (ipilimumab) demonstrated a significant improvement in overall survival (OS) in patients with previously untreated, unresectable malignant pleural mesothelioma (MPM) in the Phase 3 CheckMate -743 clinical trial. With a minimum follow-up of 22 months, treatment with Opdivo plus Yervoy reduced the risk of death by …

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Guardant Health Guardant360 CDx First FDA-Approved Liquid Biopsy for Comprehensive Tumor Mutation Profiling Across All Solid Cancers

REDWOOD CITY, Calif., Aug. 07, 2020 (GLOBE NEWSWIRE) — Guardant Health, Inc. (Nasdaq: GH) announces that the U.S. Food and Drug Administration (FDA) has approved Guardant360® CDx for tumor mutation profiling, also known as comprehensive genomic profiling (CGP), in patients with any solid malignant neoplasm (cancerous tumor). The Guardant360 CDx is also …

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Phase 3 Study of Genentech’s Tecentriq in Combination with Paclitaxel in Triple-Negative Breast Cancer Fails to Meet its Primary Endpoint

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the Phase III IMpassion131 study, evaluating Tecentriq® (atezolizumab) in combination with paclitaxel (chemotherapy), in comparison to placebo plus paclitaxel, did not meet statistical significance on its primary endpoint of progression-free survival …

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