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 Approves Nivolumab for MSI-H or dMMR Colorectal Cancer
August 1st 2017The FDA has granted an accelerated approval to nivolumab for the treatment of adult and pediatric patients with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.
FDA Grants Venetoclax Breakthrough Designation for AML Subpopulation
July 29th 2017Venetoclax has received an FDA breakthrough therapy designation for use in combination with low dose cytarabine in treatment-naïve elderly patients with acute myeloid leukemia who are ineligible for intensive chemotherapy.
European Commission Approves Frontline Fulvestrant for ER+ Breast Cancer
July 28th 2017The European Commission has approved the use of fulvestrant (Faslodex) to treat estrogen receptor-positive, locally-advanced or metastatic breast cancer in postmenopausal women not previously treated with endocrine therapy.