Notizie AIOM – anno XVII n. 730
Regorafenib dose-optimisation in patients with refractory metastatic colorectal cancer (ReDOS): a randomised, multicentre, open-label, phase 2 study
Regorafenib confers an overall survival benefit in patients with refractory metastatic colorectal cancer; however, the adverse event profile of regorafenib has limited its use. Despite no supportive evidence, various dosing schedules are used clinically to alleviate toxicities. ...Leggi tutto
FDA Approval Sought for Neratinib Combo in HER2+ Breast Cancer
July 1, 2019 - A supplemental new drug application (sNDA) has been submitted to the FDA 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 ...Leggi tutto
FDA Approves Avatrombopag in Chronic ITP
July 1, 2019 - The FDA has approved a supplemental new drug application (sNDA) to expand the use of avatrombopag to include the treatment of adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to prior therapy. The approval of ...Leggi tutto
Statement on steps to make health care professional and patient labeling information for prescription medications consistent and clear
July 1, 2019 - The FDA is committed to making sure that health care professionals and patients have up-to-date, accurate and actionable information about prescription medications so that informed treatment decisions can be made. We recognize that the choice of which medication ...Leggi tutto
Cemiplimab Approved in Europe for Cutaneous Squamous Cell Carcinoma
July 1, 2019 - The European Commission approved cemiplimab for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) who are not candidates for curative surgery or curative radiation, according to Regeneron Pharmaceuticals ...Leggi tutto
Call for all sponsors to publish clinical trial results in EU database
July 3, 2019 - The European Commission (EC), the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have co-signed a letter reminding all sponsors of clinical trials conducted in the European Union of their obligation to make summaries of results of ...Leggi tutto
Medicine shortages: EU network takes steps to improve reporting and communication
July 4, 2019 - The European Union task force set up to address problems with medicines supply has published two documents today: guidance for marketing authorisation holders on reporting of shortages in the EU; good practice guidance for communication to the public on medicines’ ...Leggi tutto
Lung Cancer Incidence and Mortality with Extended Follow-up in the National Lung Screening Trial. National Lung Screening Trial Writing Team 1
The National Lung Screening Trial (NLST) randomized high-risk current and former smokers to 3 annual screens with either low-dose computed tomography (LDCT) or chest radiographs (CXR) and demonstrated a significant reduction in lung cancer mortality in the LDCT arm after ...Leggi tutto