Home / Oncology (page 5)

Oncology

FDA Grants Orphan Drug Designation to TG Therapeutics’ Umbralisib for the Treatment of Marginal Zone Lymphoma

NEW YORK, April 15, 2019 (GLOBE NEWSWIRE) — TG Therapeutics, Inc. (NASDAQ: TGTX) today announced that the U.S. Food and Drug Administration (FDA) granted orphan drug designation to its phosphoinositide-3-kinase (PI3K) delta inhibitor, umbralisib (TGR-1202), for the treatment of patients with all three types of marginal zone lymphoma (MZL): nodal, extranodal, and splenic …

Read More »

FDA Approves Janssen’s Balversa for Treatment of Patients with Urothelial Carcinoma with Certain Genetic Alterations

HORSHAM, Pa., April 12, 2019  — The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that BALVERSA™ (erdafitinib) received accelerated approval from the U.S. Food and Drug Administration (FDA) for the treatment of adults with locally advanced or metastatic urothelial carcinoma (mUC) which has susceptible fibroblast growth factor receptor …

Read More »

FDA Approves Expanded Monotherapy Label for Merck’s Keytruda in Non-Small Cell Lung Cancer

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded label for KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the first-line treatment of patients with stage III non-small cell lung cancer (NSCLC) who …

Read More »

Bayer Announces Results of Sub-group Analysis for Vitrakvi in Patients with NTRK Gene Fusion-Positive Metastatic NSCLC

WHIPPANY, N.J., April 11, 2019 /PRNewswire/ — Bayer today presented subgroup analysis data of patients with non-small cell lung cancer with neurotrophic receptor tyrosine kinase (NTRK) gene fusion treated with Vitrakvi® (larotrectinib).1 Vitrakvi is the only TRK inhibitor exclusively designed for the treatment of adult and pediatric patients with solid …

Read More »

Newly Published Independent, Prospective Study Reinforces Prognostic Accuracy of DecisionDx-Melanoma in Cutaneous Melanoma

FRIENDSWOOD, Texas–(BUSINESS WIRE)–Castle Biosciences, Inc., a skin cancer diagnostics company providing personalized genomic information to improve cancer management decisions, today announced publication of an independent, prospective study of 159 patients with cutaneous melanoma showing that the DecisionDx®-Melanoma gene expression profile (GEP) test accurately identified risk of melanoma recurrence independent of …

Read More »

Concerto HealthAI Enters Precision Oncology Collaboration with Pfizer

Concerto HealthAI announced today that they have entered into a collaboration with Pfizer to advance work in Precision Oncology using Concerto HealthAI’s eurekaHealthTM platform, artificial intelligence (AI) models and Real World Clinical Electronic Medical Record (EMR) and healthcare claims. Data from clinical practices participating in the American Society of Clinical Oncology’s CancerLinQ® initiative …

Read More »

Foundation Medicine and Flatiron Publish Validation of Clinico-Genomic Database as a Platform to Advance Oncology Drug Development and Personalized Cancer Care

CAMBRIDGE, Mass. & NEW YORK–(BUSINESS WIRE)–Foundation Medicine and Flatiron Health today announced the publication of study results in the Journal of the American Medical Association validating that real-world clinico-genomic data obtained during the course of routine patient care can yield scientifically and clinically meaningful insights. These insights can serve as real-world evidence …

Read More »

BioAtla and BeiGene Form Worldwide Collaboration to Develop and Commercialize Novel Conditionally Active Biologic CTLA-4 Therapy

SAN DIEGO and BEIJING, China and CAMBRIDGE, Mass., April 09, 2019 (GLOBE NEWSWIRE) — BioAtla ®, LLC, a global clinical-stage biotechnology company focused on the development of Conditionally Active Biologic (CAB) protein therapeutics, and BeiGene, Ltd. (Nasdaq: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted …

Read More »

Merrimack Discontinues Development of its Investigational Solid Tumor Candidate MM-310

CAMBRIDGE, Mass., April 4, 2019 /PRNewswire/ — Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK), an oncology company focused on biomarker-defined cancers, today announced the Company is discontinuing development of MM-310, its antibody-directed nanotherapeutic for the treatment of solid tumors. This decision was the result of a comprehensive review of available safety data …

Read More »

FDA Expands Approval of Pfizer’s Ibrance for Treatment of Men with Metastatic Breast Cancer

The U.S. Food and Drug Administration today is extending the indication of Ibrance (palbociclib) capsules in combination with specific endocrine therapies for hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in male patients. “Today we are expanding the indication for Ibrance to include …

Read More »