Notizie Newsletter
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
Lung cancer and end-of-life care: a systematic review and thematic synthesis of aggressive inpatient care
Despite recent advances in thoracic oncology, most patients with metastatic lung cancer die within months of diagnosis. Aggressiveness of their end-of-life (EOL) care has been the subject of numerous studies. This study was undertaken to evaluate the literature on aggressive ...Leggi tutto
FDA Issues Warning on Severe Lung Inflammation With CDK4/6 Inhibitors in Breast Cancer
Sep 13, 2019 - The FDA is updating the prescribing information and Patient Package Insert for the CDK4/6 inhibitors palbociclib, ribociclib, and abemaciclib to include a warning that the treatments in rare cases may cause severe inflammation of the lungs. The inflammation ...Leggi tutto