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Oncology

Bayer Announces the FDA Accepted the NDA and Granted Priority Review to Darolutamide for Treatment of Non-Metastatic Castration-resistant Prostate Cancer

WHIPPANY, N.J., April 29, 2019 /PRNewswire/ — Bayer today announced the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) and granted Priority Review to darolutamide for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC). The NDA and Priority Review status were based on data from …

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Merck Provides Update on Phase 3 Trial Evaluating Keytruda for Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced topline findings from the final analysis of the pivotal Phase 3 KEYNOTE-062 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy and in combination with chemotherapy (cisplatin and either 5-fluorouracil or capecitabine) for the first-line …

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Daiichi Sankyo Selects Lead Candidate Built on Zymeworks’ Azymetric Bispecific Platform

VANCOUVER, British Columbia VANCOUVER, British Columbia & TOKYO & BASKING RIDGE, N.J.–(BUSINESS WIRE)–Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, and Daiichi Sankyo Company, Limited (“Daiichi Sankyo”) announced today that Daiichi Sankyo has exercised its option for a commercial license to a proprietary immuno-oncology bispecific built on …

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Trovagene Announces Data Demonstrating Significant Synergy of Onvansertib in Combination with Venetoclax in Cell Model of Venetoclax-Resistant AML

SAN DIEGO, April 23, 2019 /PRNewswire/ — Trovagene, Inc. (Nasdaq:  TROV), a clinical-stage oncology therapeutics company, taking a precision medicine approach to develop drugs that target cell division (mitosis) for the treatment of leukemias, lymphomas and solid tumor cancers, today announced preclinical data that evaluated the effect of combining onvansertib …

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Autolus Therapeutics Receives FDA Orphan Drug Designation for AUTO3 for Treatment of Acute Lymphoblastic Leukemia

LONDON, April 23, 2019 (GLOBE NEWSWIRE) — Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies for the treatment of cancer, announced that the United States Food and Drug Administration (FDA) has granted orphan drug designation to autologous enriched T-cells genetically modified with a retroviral …

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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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