Zanubrutinib for WM | Deauville 5PS | Tivozanib for RCCMarch 23, 2021 | Oncology Hematology FDA Accepts sNDA for Zanubrutinib in Waldenström Macroglobulinemia More good news for zanubrutinib, which received accelerated approval in November 2019 in the US for the treatment of mantle cell lymphoma (MCL) in adult patients who have undergone at least one prior therapy. The supplemental new drug application (sNDA) was submitted by the drug’s manufacturer, BeiGene, based on data from the global phase III ASPEN trial. Read full article Hematology Deauville Five-Point Scale This article from Radiopaedia discusses inclusions, usage, assessment of treatment response, caveats, history, and etymology of the internationally recognized Deauville five-point scale (Deauville 5PS), which was proposed in an international workshop attended by hematologists and nuclear medicine specialists in Deauville, France in 2009. Read full article Hematology/Oncology FDA Approves Tivozanib for R/R Advanced RCC The approval of the drug (Fotivda, Aveo Pharmaceuticals) was based on the results of the open-label, multi-center TIVO-3 trial, which looked at progression-free survival (PFS) as the main efficacy endpoint, assessed by a blinded independent radiology review committee. Secondary end points included overall survival (OS) and objective response rate (ORR). Read full article
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