Notizie AIOM – anno XVII
FDA Grants Fast Track Designation to AMG 510 for KRAS G12C+ NSCLC
Sep 9, 2019 - The FDA has granted a fast track designation to the investigational KRAS inhibitor AMG 510 for the treatment of patients with KRAS G12C-mutated non-small cell lung cancer (NSCLC) who have received prior treatment. The decision is based on updated phase I data ...Leggi tutto
FDA Accepts sNDA for Neratinib Combo for HER2+ Breast Cancer
Sep 11, 2019 - The FDA has accepted a supplemental new drug application (sNDA) for neratinib for use in combination with capecitabine for the treatment of patients with HER2-positive metastatic breast cancer who have failed at least 2 prior lines of HER2-directed treatments. ...Leggi tutto
FDA Grants Tepotinib Breakthrough Designation for METex14-Altered NSCLC
Sep 11, 2019 - The FDA has granted a breakthrough therapy designation to the investigational MET inhibitor tepotinib as a treatment for patients with metastatic non–small cell lung cancer (NSCLC) with MET exon14-skipping (METex14) alterations who have progressed on ...Leggi tutto
Trends in the Prevalence of Exposure to e-Cigarette Aerosol in Public Places Among US Middle and High School Students, 2015 to 2018
Approximately one-quarter of US youth were exposed to secondhand electronic cigarette (e-cigarette) aerosols between 2015 and 2017.1 Given the rapid increase in vaping and the popularity of pod-based e-cigarettes among youth,2 this survey study examines trends in and factors ...Leggi tutto
ASCO Expands Therapeutic Options for Venous Thromboembolism Prophylaxis in Patients With Cancer
Sep 4, 2019 - ASCO has updated its recommendations for the prevention and treatment of venous thromboembolism (VTE) in patients with cancer. “The recommendations were last updated in 2015, but since then, new, significant publications have emerged, which prompted this ...Leggi tutto
FDA Grants Nirogacestat Breakthrough Designation for Desmoid Tumors
Sep 4, 2019 - The FDA has granted a breakthrough therapy designation to the investigational gamma-secretase inhibitor nirogacestat (PF-03084014) for the treatment of adult patients with progressive, unresectable, recurrent or refractory desmoid tumors or deep fibromatosis. ...Leggi tutto
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 2-5 September 2019
Sep 6, 2019 - EMA’s safety committee (PRAC) has started a review of data on skin cancer in patients using Ingenol mebutate (LEO), a gel for treating actinic keratosis, a skin condition caused by too much sunlight exposure. The review was triggered by data from several ...Leggi tutto
Atezolizumab Combo Approved in Europe for Small Cell Lung Cancer
Sep 6, 2019 - The European Commission has approved atezolizumab for use in combination with carboplatin and etoposide for the frontline treatment of adult patients with extensive-stage small cell lung cancer, according to Roche (Genentech) the developer of the PD-L1 inhibitor. ...Leggi tutto
Frontline Atezolizumab Plus Carboplatin/Nab-Paclitaxel Approved in Europe for Nonsquamous NSCLC
Sep 6, 2019 - The European Commission has approved atezolizumab for use in combination with carboplatin and nab-paclitaxel for the first-line treatment of adult patients with advanced, nonsquamous non–small cell lung cancer (NSCLC) who do not have EGFR or ALK molecular ...Leggi tutto