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 Naxitamab Priority Review for Relapsed/Refractory High-Risk Neuroblastoma
June 3rd 2020The FDA has granted a priority review designation to a biologics license application for the investigational, humanized monoclonal antibody naxitamab (Danyelza) for the treatment of patients with relapsed/refractory high-risk neuroblastoma.
Addition of Veliparib to Cisplatin Significantly Improves PFS in BRCA-Like Advanced TNBC
June 2nd 2020The addition of veliparib to cisplatin resulted in a significant improvement in progression-free survival and a trend toward improved overall survival in patients with BRCA-like triple-negative breast cancer.
Olaparib Approaches EU Approval for Frontline Maintenance in Pancreatic Cancer
June 1st 2020The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended olaparib for the maintenance treatment of adult patients with germline BRCA-mutated metastatic pancreatic adenocarcinoma.
Palbociclib Falls Short in Phase 3 Early Breast Cancer Trial
June 1st 2020The phase 3 PALLAS trial exploring palbociclib (Ibrance) in patients with HR-positive, HER2-negative early breast cancer is unlikely to demonstrate a statistically significant improvement in the study’s primary end point of invasive disease-free survival.
EU Panel Backs Entrectinib for NTRK+ Tumors and ROS1+ NSCLC
June 1st 2020The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended entrectinib for the treatment of adult and pediatric patients ≥12 years of age with solid tumors that harbor an NTRK fusion, as well as for the treatment of adult patients with ROS1-positive, advanced non–small cell lung cancer not previously treated with ROS1 inhibitors.
Maintenance Niraparib Boosts PFS in Phase 3 Study of Chinese Patients With Ovarian Cancer
May 29th 2020Maintenance niraparib improved progression-free survival in Chinese patients with recurrent ovarian cancer who were in a complete or partial response to platinum-based chemotherapy, meeting the primary end point of the phase 3 NORA study.
Orthopedic Oncologists Recommended for Consult on Bone Sarcoma Treatment After Osteointegration
May 26th 2020R. Lor Randall, MD, FACS, discusses the cautions medical oncologists should take for their patients with bone sarcomas who undergo limb preservation with osteointegration, and the importance of keeping orthopedic oncologists in the loop.