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Oncology

Dragonfly and Celgene Expand Collaboration in Immunotherapies for Patients with Solid and Hematological Cancers

WALTHAM, Mass., Nov. 14, 2018 /PRNewswire/ — Dragonfly Therapeutics, Inc. (“Dragonfly” or the “Company”), today announced it entered into a new agreement with Celgene Corporation and its affiliates (“Celgene”) to discover, develop and commercialize innovative immunotherapies for patients with solid and hematological cancers. The new agreement builds upon Celgene’s existing …

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Merck’s Keytruda Significantly Improved Overall Survival Compared to Chemotherapy in Certain Patients with Advanced Esophageal or Esophagogastric Junction Carcinoma

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that the Phase 3 KEYNOTE-181 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy in the second-line treatment of advanced or metastatic esophageal or esophagogastric junction carcinoma has met a primary endpoint of overall survival (OS) …

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FDA Grants Priority Review to Genentech’s Tecentriq in Combination with Abraxane for PD-L1-Positive Metastatic TNBC

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for Tecentriq® (atezolizumab) plus chemotherapy (Abraxane® [albumin-bound paclitaxel; nab-paclitaxel]) for the initial (first-line) treatment of …

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FDA Grants Priority Review to Lynparza sNDA as Maintenance Therapy for Newly-Diagnosed, BRCAm Advanced Ovarian Cancer

WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca and Merck & Co., Inc., Kenilworth, N.J., US (Merck: known as MSD outside the US and Canada) today announced that the US Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) and granted priority review for the approval of LYNPARZA (olaparib) (two 150 mg …

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FDA Provides Accelerated Approval to Merck’s Keytruda for Treatment of Patients with Hepatocellular 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, for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under …

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Obsidian Presents Preclinical Data Demonstrating Precise Regulation of Cytokines and CAR in T cells with Destabilizing Domain Technology using FDA-Approved Drugs

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Obsidian Therapeutics, Inc., a biotechnology company developing cell therapies with pharmacologic operating systems, today announced the presentation of preclinical data demonstrating fine-tuned regulation of cytokine production and CAR-T function using Destabilizing Domains (DDs) paired with FDA-approved small molecule drugs. Obsidian will reveal a suite of novel human DDs …

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SELLAS Life Sciences Announces Additional Data Showing Consistent Clinical Effect Across HLA Allele Subgroups in Triple Negative Breast Cancer Patients Treated with Nelipepimut-S Plus Trastuzumab

NEW YORK, Nov. 09, 2018 (GLOBE NEWSWIRE) — SELLAS Life Sciences Group, Inc. (Nasdaq:SLS) (“SELLAS” or the “Company”), a clinical-stage biopharmaceutical company focused on the development of novel cancer immunotherapies for a broad range of cancer indications, today announced data from a preplanned secondary efficacy analysis across human leukocyte antigen …

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Celldex Presents Promising Interim Data from Phase 1 Study of Differentiated CD40 Agonist CDX-1140

HAMPTON, N.J., Nov. 09, 2018 (GLOBE NEWSWIRE) — Celldex Therapeutics, Inc. (NASDAQ:CLDX) presented interim data today from the Phase 1 dose-escalation study of CDX-1140, a fully human agonist anti-CD40 antibody. CD40, expressed on dendritic cells and other antigen presenting cells, has long been an important target for immunotherapy, as it …

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New Data Support Ongoing Clinical Program for Lenvima and Keytruda Combination Across Multiple Tumor Types

TOKYO & KENILWORTH, N.J.–(BUSINESS WIRE)–Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced results from presentations of new data and analyses of LENVIMA® (lenvatinib), an orally available kinase inhibitor discovered by Eisai, in combination with Merck’s anti-PD-1 …

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CRISPR Therapeutics Gains Additional Rights to MaxCyte’s Cell Engineering Technology to Develop CRISPR/Cas9-Based Cell Therapies

ZUG, Switzerland and CAMBRIDGE, Mass. and GAITHERSBURG, Md., Nov. 09, 2018 (GLOBE NEWSWIRE) — CRISPR Therapeutics (NASDAQ:CRSP) and MaxCyte today announced the expansion of their existing relationship by entering into a non-exclusive commercial license agreement that will allow CRISPR Therapeutics to deploy MaxCyte’s Flow Electroporation®Technology to develop CRISPR/Cas9-based therapies in …

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