Notizie AIOM – anno XV
14 agosto 2017 – Pubblicazione schede di monitoraggio Registro Venetoclax
Leggi tuttoFDA 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