Notizie AIOM – anno XV n. 640
FDA Accepts sBLAs for 4-week Nivolumab Dosing Schedule
July 25, 2017 - The FDA has accepted a supplemental Biologics License Applications (sBLAs) seeking to add a second dosing schedule for nivolumab across all of the PD-1 inhibitor’s monotherapy indications, according to Bristol-Myers Squibb (BMS). If approved, doctors ...Leggi tutto
FDA Approves Nivolumab for MSI-H or dMMR Colorectal Cancer
August 1, 2017 - The FDA has granted an accelerated approval to nivolumab for the treatment of adult and pediatric patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) that has progressed following ...Leggi tutto
FDA Approves Enasidenib for IDH2-Mutated AML
August 1, 2017 - The FDA has approved enasidenib as a treatment for patients with relapsed or refractory IDH2-mutated acute myeloid leukemia (AML), based on findings from a phase I/II study. A companion diagnostic, the RealTime IDH2 Assay, was also approved for the detection ...Leggi tutto
FDA Grants Acalabrutinib Breakthrough Designation in MCL
August 1, 2017 - The FDA has granted acalabrutinib a breakthrough therapy designation for patients with previously-treated mantle cell lymphoma (MCL), according to AstraZeneca, the manufacturer of the highly selective, potent BTK inhibitor. The breakthrough designation, ...Leggi tutto
FDA Approves CPX-351 for Two Types of AML
August 3, 2017 - The FDA has approved CPX-351, a fixed-combination of daunorubicin and cytarabine, for adult patients with newly diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC), based on an improvement in overall ...Leggi tutto
FDA Grants Frontline Alectinib Priority Review for ALK-Positive NSCLC
August 3, 2017 - The FDA has granted a priority review to a supplemental new drug application (sNDA) for alectinib for the frontline treatment of patients with ALK-positive locally advanced or metastatic non–small cell lung cancer (NSCLC), according to Genentech (Roche), ...Leggi tutto
EU Approval Sought for Axicabtagene Ciloleucel in Non-Hodgkin Lymphoma
July 31, 2017 - Kite Pharma has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for axicabtagene ciloleucel (axi-cel) to treat 3 forms of non-Hodgkin lymphoma (NHL). Axi-cel, an anti-CD19 chimeric antigen receptor (CAR) T cell ...Leggi tutto
Web-app
Una nuova web-app gratuita, in otto lingue, per computer, tablet e smartphone sul melanoma è disponibile sul sito del Corriere della Sera in collaborazione con l'Associazione Italiana di Oncologia Medica (leggi e scarica). Strumento interattivo in due versioni, per ...Leggi tutto