lunedì, 4 maggio 2026

Notizie AIOM – anno XVII

FDA Grants Niraparib Breakthrough Designation for BRCA+ mCRPC

Oct 3, 2019 - The FDA has granted a breakthrough therapy designation to the PARP inhibitor niraparib for the treatment of patients with BRCA1/2–mutant metastatic castration-resistant prostate cancer (mCRPC) who have previously received taxane-based chemotherapy and ...
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How to ensure that novel analytic methods are fit for decision-making

Oct 2, 2019 - The past decade has seen the increased generation and availability of new data sources such as real-world evidence, as well as patient-level data from completed randomised clinical trials. While these data provide an opportunity to learn more about a medicine’s ...
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3 ottobre 2019 – Aggiornamento sulla carenza del farmaco Mitomicina C (Kyowa Kirin)

4 ottobre 2019 – Pubblicato il 18° Rapporto nazionale AIFA sulla Sperimentazione Clinica dei medicinali

The Value of Progression-Free Survival as a Treatment End Point Among Patients With Advanced Cancer: A Systematic Review and Qualitative Assessment of the Literature

It is unclear whether patients with advanced cancer value surrogate end points, particularly progression-free survival (PFS). Despite this uncertainty, surrogate end points form the basis of regulatory approval for the majority of new cancer treatments. To summarize and ...
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1 ottobre 2019 – Registri AIFA: informazioni sui dati dei trattamenti con i nuovi farmaci per la cura dell’epatite C

2 ottobre 2019 – AIFA: vaccini influenzali per la stagione 2019-2020

3 ottobre 2019 – Nota Informativa Importante su Ondansetron

FDA informs patients, providers and manufacturers about potential cybersecurity vulnerabilities for connected medical devices and health care networks that use certain communication software

Oct 1, 2019 - Today, the U.S. Food and Drug Administration is informing patients, health care professionals, IT staff in health care facilities and manufacturers of a set of cybersecurity vulnerabilities, referred to as “URGENT/11,” that—if exploited by ...
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NCCN Grants Category 1 Recommendation to Pexidartinib for TGCT

Sep 26, 2019 - The National Comprehensive Cancer Network (NCCN) has updated its Clinical Practice Guidelines in Oncology for Soft Tissue Sarcoma to include a category 1 recommendation for pexidartinib for the treatment of patients with tenosynovial giant cell tumor (TGCT). ...
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