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.
EMA Panel Backs Approval of Lutathera for GEP-NETs
July 21st 2017The European Medicines Agency's Committee for Medicinal Products for Human Use has recommended approval of Lutathera for the treatment of patients with unresectable or metastatic, progressive, well-differentiated, somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors.
Avelumab Recommended for EU Approval for Merkel Cell Carcinoma
July 21st 2017The European Medicines Agency's Committee for Medicinal Products for Human Use has recommended approval of avelumab (Bavencio) for adults with metastatic Merkel cell carcinoma, according to Pfizer and Merck, the codevelopers of the PD-L1 inhibitor.
Bendamustine Plus Rituximab Maintains Frontline PFS Benefit in MCL, iNHL After 5 Years
July 17th 2017Five-year follow-up from the BRIGHT study confirmed that bendamustine plus rituximab is associated with improved progression-free survival compared with R-CHOP or R-CVP in patients with mantle cell lymphoma or indolent non-Hodgkin lymphoma.
Amgen Files sNDAs for Carfilzomib to Treat Multiple Myeloma in Europe, US
July 14th 2017Amgen has announced that it has submitted supplemental New Drug Applications (sNDA) in the United States and Europe based on data from 2 phase III studies showing carfilzomib (Kyprolis) improves overall survival (OS) for patients with relapsed/refractory multiple myeloma.
Predictive Factors Found for Treatment With FCO in CLL
July 14th 2017A mutation on the NOTCH1 gene was shown to be an independent predictive factor for the reduced efficacy of ofatumumab (Arzerra), a human monoclonal CD20 antibody, in the treatment of patients with relapsed/refractory chronic lymphocytic leukemia.
Encouraging Activity Seen With Glembatumumab Vedotin in Advanced Melanoma
July 14th 2017The antibody-drug conjugate glembatumumab vedotin demonstrated an 11% overall response rate in patients with refractory advanced melanoma who had received prior treatment with a checkpoint inhibitor and duration of response.
Obinutuzumab and Bendamustine Combo Shows Encouraging Activity in Upfront CLL
July 14th 2017The anti-CD20 monoclonal antibody obinutuzumab (Gazyva) combined with bendamustine (Treanda; BG) in the frontline setting for patients with chronic lymphocytic leukemia was found to induce high rates of complete response and minimal residual disease negativity with no unexpected safety signals, according to results from a phase II open-label, multicenter study.