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 Approval Sought for Enfortumab Vedotin for Urothelial Cancer
July 16th 2019A biologics license application has been submitted to the FDA for enfortumab vedotin for the treatment of patients with locally advanced or metastatic urothelial cancer who have previously received a PD-1/PD-L1 inhibitor and who have received a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced, or metastatic setting.
Frontline Maintenance Niraparib Improves PFS in Ovarian Cancer
July 15th 2019Niraparib as a maintenance treatment demonstrated a statistically significant improvement in progression-free survival compared with placebo in patients with ovarian cancer following first-line platinum-based chemotherapy, regardless of biomarker status, meeting the primary endpoint of the phase III PRIMA (ENGOT-OV26/GOG-3012) trial.
Enzalutamide Could Have Pivotal Role in Metastatic Hormone-Sensitive Prostate Cancer
July 12th 2019Christopher Sweeney, MBBS, discusses the results of the ENZAMET trial and the next steps for researching the efficacy of enzalutamide in the treatment of patients with metastatic hormone-sensitive prostate cancer.
FDA Approval Sought for Extended Pembrolizumab Dosing Schedule for Select Indications
July 9th 2019The FDA has accepted 6 supplemental biologics license applications for review to update the dosing schedule for pembrolizumab (Keytruda) to include an every-6-weeks option at 400 mg over 30-minute infusions.