martedì, 11 agosto 2026

Notizie AIOM – anno XVII n. 704

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). ...
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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). ...
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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 ...
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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 ...
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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 ...
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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 ...
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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, ...
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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 ...
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FDA Approves Dasatinib for Pediatric Ph+ ALL

January 2, 2019 - The FDA has approved dasatinib tablets in combination with chemotherapy for the treatment of pediatric patients ≥1 year of age with newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL). The approval was based ...
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EU Panel Backs Dasatinib for Pediatric Ph+ ALL

December 17, 2018 - The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has granted a positive opinion to dasatinib in combination with chemotherapy for the treatment of pediatric patients with newly diagnosed Philadelphia chromosome (Ph)-positive ...
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