The OncLive® News page includes the latest in clinical oncology news, including breaking regulatory decisions, clinical trial findings, pivotal and practice-changing data published in academic peer-reviewed journals, and more across solid and hematologic malignancies. Regulatory news includes new drug approvals by the FDA and European Union, priority review and breakthrough therapy designations, and orphan drug and fast track statuses.
Expert Highlights Progress With Molecular Biomarkers in GI Cancers
March 1st 2018Michael J. Pishvaian, MD, discusses expanded testing for biomarkers, using liquid biopsies to predict response to treatment, and the importance of identifying increasingly specific subsets of GI cancers to make treatment decisions.
FDA Approves Frontline Abemaciclib for HR+/HER2- Advanced Breast Cancer
February 27th 2018The FDA has approved abemaciclib for use in combination with an aromatase inhibitor for the frontline treatment of postmenopausal women with hormone receptor-positive, HER2-negative advanced or metastatic breast cancer.
Gemtuzumab Ozogamicin Approaches EU Approval for CD33+ AML
February 27th 2018The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval of gemtuzumab ozogamicin for use in combination with daunorubicin and cytarabine as a frontline treatment for patients aged 15 years and older with previously untreated, de novo CD33-positive acute myeloid leukemia, except acute promyelocytic leukemia.
European Panel Recommends Against Adjuvant Sunitinib for High-Risk RCC
February 27th 2018The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended against approving sunitinib for use as an adjuvant therapy in patients with renal cell carcinoma who have received nephrectomy and are high risk for recurrence.
Flexible Scope Indication Approved for Bladder Imaging Agent
February 26th 2018The FDA recently approved a supplemental new drug application for Blue Light Cystoscopy with Cysview for surveillance of bladder cancer. Cysview is currently indicated for use for detection of nonmuscle-invasive bladder cancer.
EU Panel Recommends Olaparib Tablets for Ovarian Cancer, Regardless of BRCA Status
February 24th 2018The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval of olaparib tablets (Lynparza) as a maintenance therapy for patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.
European Panel Recommends Against Neratinib for HER2-Positive Breast Cancer
February 23rd 2018European regulators have recommended against approving a marketing authorization application for the use of neratinib (Nerlynx) as extended adjuvant treatment for women with early stage HER2-positive breast cancer.