Notizie AIOM – anno XVII
Cost-utility analysis of germline BRCA1/2 testing in women with high-grade epithelial ovarian cancer in Spain
Germline mutations in BRCA1 and/or BRCA2 genes (gBRCA1/2m) are associated with an increased risk of breast cancer (BC) and ovarian cancer (OC). The aim of this study was to estimate the efficiency of providing germline BRCA1/2 testing to high-grade epithelial ovarian cancer ...Leggi tutto
Pembrolizumab Granted 5 Additional Approvals in Japan
January 3, 2019 - The Japan Pharmaceuticals and Medical Devices Agency (PMDA) has approved pembrolizumab for 5 new indications, including melanoma, advanced microsatellite instability-high (MSI-H) tumors, and 3 expanded uses in advanced non–small cell lung cancer (NSCLC). ...Leggi tutto
ASCO, ESMO Publish Joint Assessment of Their Value Frameworks
December 17, 2018 - The American Society of Clinical Oncology (ASCO) and the European Society for Medical Oncology (ESMO) today published a joint analysis comparing the results of both organizations’ value frameworks in ASCO’s Journal of Clinical Oncology (JCO). ...Leggi tutto
Lori J. Pierce, MD, FASTRO, FASCO, Elected ASCO President for 2020-2021 Term
December 18, 2018 - The American Society of Clinical Oncology (ASCO) has elected Lori J. Pierce, MD, FASTRO, FASCO, a long-time member and volunteer, to serve as its President for the term beginning in June 2020. She will take office as President-Elect during the ASCO Annual ...Leggi tutto
FDA Approves Trastuzumab Biosimilar for HER2+ Breast Cancer
December 17, 2018 - The FDA has granted an approval to CT-P6 (trastuzumab-pkrb), a trastuzumab biosimilar, for the treatment of patients with HER2-overexpressing breast cancer, according to Celltrion and Teva Pharmaceutical Industries, the co-developers of the agent. CT-P6 ...Leggi tutto
FDA Approves Olaparib for Frontline Maintenance in Ovarian Cancer
December 19, 2018 - The FDA has approved olaparib as a maintenance treatment for patients with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response ...Leggi tutto
FDA Issues Guidance on Endpoints for Cancer Clinical Trials
December 20, 2018 - This week, the U.S. Food and Drug Administration (FDA) issued a guidance titled Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics. The guidance provides recommendations to applicants on endpoints for cancer clinical trials submitted ...Leggi tutto
FDA Approves Tagraxofusp for Rare Hematologic Cancer
December 21, 2018 - The FDA has approved tagraxofusp-erzs (SL-401) infusion for the treatment of adult and pediatric patients, aged ≥2 years, with blastic plasmacytoid dendritic cell neoplasm (BPDCN). The approval is based on data from 2 cohorts of a multicenter, open-label, ...Leggi tutto
FDA Delays Decision on Frontline Pembrolizumab sBLA in NSCLC
December 21, 2018 - The FDA has extended the review period for a supplemental biologics license application (sBLA) for single-agent pembrolizumab for the frontline treatment of patients with locally advanced or metastatic nonsquamous or squamous non–small cell lung ...Leggi tutto