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.
FDA Grants Frontline Obinutuzumab Priority Review for Follicular Lymphoma
August 28th 2017The FDA has granted a priority review to a supplemental biologics license application for obinutuzumab (Gazyva) in combination with chemotherapy, followed by obinutuzumab alone, for the first-line treatment of patients with follicular lymphoma.
Frontline Ribociclib Approved in Europe for HR+/HER2- Breast Cancer
August 24th 2017The European Commission has approved the CDK 4/6 inhibitor ribociclib for use in combination with an aromatase inhibitor for the frontline treatment of postmenopausal women with hormone-receptor (HR)–positive, HER2-negative locally advanced or metastatic breast cancer.