Notizie AIOM – anno XVII
FDA takes first action under new international collaboration with Australia and Canada designed to provide a framework for concurrent review of cancer therapies, approving treatment for patients with endometrial carcinoma
Sep 17, 2019 - The U.S. Food and Drug Administration is announcing Project Orbis, an initiative of the FDA Oncology Center of Excellence (OCE). Project Orbis provides a framework for concurrent submission and review of oncology drugs among its international partners. Under ...Leggi tutto
FDA Approves Lenvatinib/Pembrolizumab Combo for Advanced Endometrial Cancer
Sep 17, 2019 - The FDA has granted an accelerated approval to the combination of lenvatinib and pembrolizumab for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), and who ...Leggi tutto
EU Panel Backs Avelumab/Axitinib Combo for Frontline RCC
Sep 20, 2019 - The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion to recommend approval of the combination of avelumab and axitinib for the frontline treatment of adult patients with advanced renal cell ...Leggi tutto
Niraparib Maintenance Therapy in Patients With Recurrent Ovarian Cancer After a Partial Response to the Last Platinum-Based Chemotherapy in the ENGOT-OV16/NOVA Trial
In the ENGOT-OV16/NOVA trial (ClinicalTrials.gov identifier: NCT01847274), maintenance therapy with niraparib, a poly(ADP-ribose) polymerase inhibitor, prolonged progression-free survival in patients with platinum-sensitive, recurrent ovarian cancer who had a response to ...Leggi tutto