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FDA Approves Merck’s Keytruda in Combination with Inlyta as First-Line Treatment for Patients with Advanced Renal Cell Carcinoma

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 KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with Inlyta (axitinib), a tyrosine kinase inhibitor, for the first-line treatment of patients with advanced renal cell carcinoma …

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Inovio Publishes Cancer Killing Data of Its Transformative DNA-encoded Bi-specific T Cell Engagers in a Peer-reviewed Journal

PLYMOUTH MEETING, Pa., April 18, 2019 /PRNewswire/ — Inovio Pharmaceuticals, Inc. (NASDAQ: INO) announced today the company’s novel DNA-encoded Bi-specific T Cell Engagers (dBiTEs) generated potent anti-tumor activities and cleared established tumors in preclinical studies. Inovio’s dBiTE results were published in a JCI Insight article entitled, “DNA-encoded bi-specific T cell …

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OncoSec and Duke University School of Medicine Collaborate in HER2+ Breast Cancer Evaluating TAVO with Plasmid DNA Vaccines

SAN DIEGO and PENNINGTON, N.J., April 17, 2019 /PRNewswire/ — OncoSec Medical Incorporated (OncoSec) (NASDAQ: ONCS), a company developing intratumoral cancer immunotherapies, and Duke University School of Medicine, today announced that they have entered into a collaborative research agreement to evaluate the use of OncoSec’s proprietary TAVOPLUS (enhanced IL-12 DNA-plasmid) …

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Agilent Receives an Expanded FDA Approval for its Companion Diagnostic in NSCLC

SANTA CLARA, Calif.–(BUSINESS WIRE)–Agilent Technologies Inc. (NYSE: A) today announced that the U.S. Food and Drug Administration has updated its approval of the company’s PD-L1 IHC 22C3 pharmDx assay. The assay can now be used as a companion diagnostic to identify a broader range of patients with stage III or metastatic …

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New Publication Validates Clinical Performance of Signatera for Recurrence Monitoring and MRD Assessment in Breast Cancer

SAN CARLOS, Calif., April 16, 2019 /PRNewswire/ — Natera, Inc. (NASDAQ: NTRA), Cancer Research UK, Imperial College London and the University of Leicester, today announced the publication of results of a clinical study demonstrating that the Signatera™ research-use-only (RUO) molecular residual disease (MRD) assay detected disease relapse up to two …

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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 …

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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 …

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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 …

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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 …

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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 …

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