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Oncology

Pfizer’s Talazoparib Granted FDA Priority Review for Metastatic Breast Cancer Patients with an Inherited BRCA Mutation

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) announced today that the U.S. Food and Drug Administration accepted for filing and granted Priority Review designation to the company’s New Drug Application for talazoparib. The submission is based on results from the EMBRACA trial, which evaluated talazoparib versus chemotherapy in patients with germline (inherited) …

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Centogene Partners with the Universities of Greifswald and Rostock to Develop Fast-Tracked Diagnostic Workflow for Personalized Therapies for Colon and Pancreatic Tumors

ROSTOCK, Germany–(BUSINESS WIRE)–CENTOGENE, the worldwide leader in using genetic and proteomic knowledge to enable patients, clinicians and pharmaceutical partners to identify and accelerate treatments for rare diseases, today announced partnering with the Medical Faculties of the Universities of Greifswald and Rostock for the research project, “Development of diagnostic tools for …

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Researchers Identify Blood-Based DNA Biomarker Panel to Accurately Diagnose Hepatocellular Carcinoma

WASHINGTON, June 5, 2018 /PRNewswire/ — Researchers at Exact Sciences Corp. (Nasdaq: EXAS) and Mayo Clinic announced significant progress toward developing a panel of novel, blood-based, DNA biomarkers that could accurately detect hepatocellular carcinoma (HCC), the most common cancer that originates in the liver.1 The researchers detailed their findings during …

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FDA Expands Lilly’s Alimta Label to Include Combination Treatment for Metastatic Nonsquamous NSCLC

INDIANAPOLIS, June 5, 2018 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) has granted approval for a new indication for ALIMTA®(pemetrexed for injection) in combination with carboplatin and KEYTRUDA® (pembrolizumab) for the initial treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), irrespective of PD-L1 …

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Lynparza in Combination with Abiraterone Delayed Disease progression in Metastatic Castration-Resistant Prostate Cancer

WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca and Merck & Co., Inc., Kenilworth, N.J., US (Merck: known as MSD outside the US and Canada) today presented data, which showed clinical improvement in median radiologic progression-free survival (rPFS) with LYNPARZA® (olaparib) in combination with abiraterone compared to abiraterone monotherapy, a current standard of care, in metastatic …

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Opdivo Demonstrates Sustained, Superior Recurrence-Free Survival Versus Yervoy in Late-Stage Melanoma Trial

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE:BMY) today announced updated results from the Phase 3 CheckMate -238 trial evaluating Opdivo (nivolumab) versus Yervoy (ipilimumab) in patients with stage IIIB/C or stage IV melanoma who are at high risk of recurrence following complete surgical resection. In updated results from the study, Opdivo continued to demonstrate statistically longer recurrence-free survival (RFS) of …

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Array Announces Additional Median Overall Survival Results of Encorafenib and Binimetinib in Patients with Braf-Mutant Advanced Melanoma

BOULDER, Colo., June 4, 2018 /PRNewswire/ — Array BioPharma Inc. (NASDAQ: ARRY) today announced updated results from the Phase 3 COLUMBUS trial in BRAF-mutant advanced melanoma. The results showed median overall survival (mOS) was 33.6 months for patients treated with the combination of encorafenib and binimetinib compared to 16.9 months for patients treated with vemurafenib as …

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Kite Announces New Data Analyses for CAR T Therapy in Patients with Blood Cancers

CHICAGO–(BUSINESS WIRE)–Kite, a Gilead Company (Nasdaq: GILD), today announced new analyses from the ZUMA chimeric antigen receptor T (CAR T) cell therapy development program that are being presented at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. The results include analyses of the ZUMA-1 study of …

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Merck’s Keytruda Shows Promise in Mid-Stage Study in Patients with Advanced Small Cell Lung Cancer

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced interim data from a cohort of the Phase 2 KEYNOTE-158 study evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy in patients with previously treated advanced small cell lung cancer (SCLC). Findings showed an overall response …

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FDA Lifts Partial Clinical Hold on Late-Stage Opdivo-Based Combination Study in Multiple Myeloma

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) lifted a partial clinical hold placed on CA209-602 (CheckMate -602), a randomized, open-label Phase 3 study evaluating the addition of Opdivo (nivolumab) to pomalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma. The decision …

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