Latest news

• NICE recommends Ibrance and Lynparza, rejects Keytruda and Xospata

  Xospata. Also receiving a no from NICE was Astellas, which received a rejection of its FLT3-inhibitor  Xospata(gilteritinib).

• Astellas stays ahead of its FLT3 rivals with EU nod for Xospata

  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

• Astellas’ Xospata scores positive CHMP recommendation

  Xospata (gilteritinib), setting up a likely approval in the EU in the near future. .

• One hit, one miss as FDA panel votes on Daiichi’s cancer drugs

  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

• Astellas, Catalyst approvals set up record year for FDA approvals

  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