Notizie AIOM – anno XVII
Hype or hope? The strange case of platinum salts’ renaissance in breast cancer
In the last decade, the clinical applicability of platinum salts in breast cancer (BC) has gained momentum, mainly in the context of homologous recombination-deficiency (HRD) where effects of DNA-damaging agents are particularly enhanced. Indeed, these agents have been traditionally ...Leggi tutto
FDA Waives ODAC Review of Luspatercept in MDS
December 6, 2019 - The FDA’s Oncologic Drugs Advisory Committee (ODAC) meeting on December 18, 2019, will no longer include a session reviewing a supplemental Biologics License Application (sBLA) for luspatercept-aamt (Reblozyl) for use as a treatment for patients ...Leggi tutto
UK Expands Olaparib Maintenance Indication in Ovarian Cancer
December 3, 2019 - The UK’s National Institute for Health and Care Excellence has approved olaparib for the maintenance treatment of adult patients with relapsed, platinum-sensitive, high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer whose ...Leggi tutto
EMA update on metformin diabetes medicines
December 6, 2019 - EMA is aware that trace amounts of an impurity, N-nitrosodimethylamine (NDMA), have been found in a small number of metformin diabetes medicines outside the EU. The levels of NDMA in the affected non-EU metformin medicines are very low and appear to be ...Leggi tutto
Olaparib in patients with metastatic castration-resistant prostate cancer with DNA repair gene aberrations (TOPARP-B): a multicentre, open-label, randomised, phase 2 trial
Metastatic castration-resistant prostate cancer is enriched in DNA damage response (DDR) gene aberrations. The TOPARP-B trial aims to prospectively validate the association between DDR gene aberrations and response to olaparib in metastatic castration-resistant prostate ...Leggi tutto
IMbrave150: Efficacy and safety results from a ph III study evaluating atezolizumab (atezo) + bevacizumab (bev) vs sorafenib (Sor) as first treatment (tx) for patients (pts) with unresectable hepatocellular carcinoma (HCC)
Ph 1b data has shown promising efficacy and safety for atezo + bev in unresectable HCC pts who have not received prior systemic therapy. Here, we report the primary analysis data from the Ph 3 IMbrave150 trial comparing atezo + bev vs sor in this pt population. IMbrave150 ...Leggi tutto