This page shows the latest gilteritinib news and features for those working in and with pharma, biotech and healthcare.
At the beginning of the year, NICE rejected Xospata (gilteritinib) citing uncertainty around the long-term survival benefit of the drug in FLT3-positive acute myeloid leukaemia (AML) patients as grounds
Xospata. Also receiving a no from NICE was Astellas, which received a rejection of its FLT3-inhibitor Xospata(gilteritinib).
The approval comes after an accelerated review of Xospata (gilteritinib) as a monotherapy for relapsed/refractory FLT3-positive AML, and just a few days after the EMA’s main advisory committee
Xospata (gilteritinib), setting up a likely approval in the EU in the near future. .
positive relapsed AML – Xospata (gilteritinib) – which picked up an FDA approval in this setting last November and was launched in Japan last December. ... Both quizartinib and gilteritinib are aimed at second-line therapy. Daiichi Sankyo acquired
The approvals of Astellas’ FLT3 inhibitor Xospata (gilteritinib) for acute myeloid leukaemia and Catalyst Pharmaceuticals’ Firdapse (amifampridine) for rare autoimmune disease Lambert-Eaton Myasthenic Syndrome (LEMS), already put the number for
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