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 Pembrolizumab/Lenvatinib Breakthrough Designation for RCC
January 9th 2018The FDA has granted the combination of the PD-1 inhibitor pembrolizumab and the VEGF/FGF inhibitor lenvatinib a breakthrough therapy designation for the treatment of patients with advanced and/or metastatic renal cell carcinoma.
Analysis Confirms Safety of Olaparib in Breast Cancer
January 5th 2018An analysis of the phase III OlympiAD study showed that treatment discontinuation due to toxicity was less frequent with olaparib (Lynparza) monotherapy in patients with HER2-negative metastatic breast cancer and a germline BRCA mutation.
FDA Grants Frontline Eltrombopag Breakthrough Designation for Severe Aplastic Anemia
January 4th 2018The FDA has granted a breakthrough therapy designation to eltrombopag (Promacta) for use in combination with standard immunosuppressive therapy as a first-line treatment for patients with severe aplastic anemia.