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.
Abiraterone Approaches EU Approval for Newly Diagnosed Hormone-Sensitive Prostate Cancer
October 16th 2017The European Medicines Agency's Committee for Medicinal Products for Human Use has recommended expanding the existing marketing authorization for abiraterone acetate (Zytiga) in men with newly diagnosed, high-risk metastatic hormone-sensitive prostate cancer.
FDA Grants Priority Review to Frontline Abemaciclib for HR+/HER2- Advanced Breast Cancer
October 12th 2017The FDA has granted a priority review to a new drug application for abemaciclib for use in combination with an aromatase inhibitor for the frontline treatment of women with hormone receptor-positive, HER2-negative advanced or metastatic breast cancer.
FDA Grants Priority Review to Afatinib for NSCLC With Rare EGFR Mutations
October 11th 2017The FDA has granted a priority review to a supplemental new drug application for afatinib for the frontline treatment of patients with metastatic non-small cell lung cancer whose tumors harbor EGFR exon 21 (L861Q), G719X, or S768I substitution mutations.
FDA Approval Sought for Maintenance Rucaparib in Ovarian Cancer
October 10th 2017A supplemental new drug application has been submitted to the FDA for rucaparib as maintenance treatment for patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.
No Survival Benefit With Abemaciclib in KRAS+ NSCLC
October 10th 2017In topline results from the phase III JUNIPER trial, abemaciclib failed to meet its primary endpoint of improving overall survival versus erlotinib in patients with KRAS-mutated, advanced non–small cell lung cancer (NSCLC) who progressed after platinum-based chemotherapy.