Oncology

Tracking Unstable Chromosomes Helps Predict Lung Cancer’s Return

Scientists have found that unstable chromosomes within lung tumors increases the risk of cancer returning after surgery, and have used this new knowledge to detect relapse long before standard testing. These are the first findings from the Cancer Research UK-funded TRACERx* lung cancer study, published today (Wednesday) in the New …

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Pfizer’s Lorlatinib Receives Breakthrough Therapy Designation from the FDA for ALK-Positive NSCLC

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. today announced that its investigational next-generation ALK/ROS1 tyrosine kinase inhibitor, lorlatinib, was granted Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC), previously treated with one or more …

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FDA Expands Approval of Bayer’s Stivarga for Treatment of Hepatocellular Carcinoma

The U.S. Food and Drug Administration today expanded the approved use of Stivarga (regorafinib) to include treatment of patients with hepatocellular carcinoma (HCC or liver cancer) who have been previously treated with the drug sorafenib. This is the first FDA-approved treatment for a liver cancer in almost a decade. “Limited …

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FDA Approves Silvergate’s XATMEP, the Only Ready-to-Use Methotrexate Oral Solution

DENVER, April 26, 2017 /PRNewswire/ — Silvergate Pharmaceuticals, Inc. (www.silvergatepharma.com), leaders in the development and commercialization of innovative and safe medicines for children, today announced that the United States Food and Drug Administration (FDA) approved XATMEP (methotrexate) Oral Solution, the first and only FDA-approved methotrexate oral solution. XATMEP is indicated …

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Lilly’s Abemaciclib Achieves Primary Endpoint in Late-Stage Breast Cancer Trial

INDIANAPOLIS, April 24, 2017 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) today announced that following a pre-planned interim analysis for MONARCH 3, the trial met its primary endpoint of demonstrating statistically significant improvement in progression-free survival (PFS). In addition, improvement was shown in a key secondary endpoint of objective response …

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FDA Takes Action Against 14 Companies for Selling Illegal Cancer Treatments

The U.S. Food and Drug Administration today posted warning letters addressed to 14 U.S.-based companies illegally selling more than 65 products that fraudulently claim to prevent, diagnose, treat or cure cancer. The products are marketed and sold without FDA approval, most commonly on websites and social media platforms. “Consumers should …

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H3 Biomedicine Extends Collaboration with Foundation Medicine to Develop Precision Therapies for Cancer

CAMBRIDGE, Mass.–(BUSINESS WIRE)–H3 Biomedicine Inc., a clinical stage biopharmaceutical company specializing in the discovery and development of precision medicines for oncology and a member of Eisai’s global Oncology Business Group, today announced that is has extended its multi-year collaboration with Foundation Medicine, Inc. for the discovery and development of precision …

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AbbVie’s PARP Inhibitor Fails Two Late-Stage Cancer Trials

NORTH CHICAGO, Ill., April 19, 2017 /PRNewswire/ — AbbVie, a global biopharmaceutical company, today announced that two Phase 3 studies evaluating veliparib, an investigational, oral poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor did not meet their primary endpoints. The studies evaluated veliparib in combination with the chemotherapy regimen carboplatin and …

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Novartis’ CAR-T Therapy Receives Breakthrough Therapy Designation for Diffuse Large B-Cell Lymphoma

Basel, April 18, 2017 – Novartis announced today that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to CTL019, an investigational chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of adult patients with relapsed and refractory (r/r) diffuse large B-cell lymphoma (DLBCL), who have …

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FDA Grants Accelerated Approval to Genentech’s Tecentriq for Treatment of Advanced Bladder Cancer

South San Francisco, CA — April 17, 2017 — Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) granted accelerated approval to TECENTRIQ® (atezolizumab) for the treatment of people with locally advanced or metastatic urothelial carcinoma (mUC) who …

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