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• 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). ... Xospata was also too costly for the usual NICE recommendation, with a list price of £14, 188 per 28-day pack.

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

  The results of that study showed Xospata extended overall survival (OS) to 9.3 months from 5.6 months in the control group. ... Xospata is the first FLT3 inhibitor to be approved for use in relapsed or refractory AML with a FLT3 inhibitor mutation.

• Astellas’ Xospata scores positive CHMP recommendation

  Xospata (gilteritinib), setting up a likely approval in the EU in the near future. . ... The decision is based on the results from Astellas’ phase 3 ADMIRAL trial investigating Xospata compared to salvage chemotherapy.

• 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. ... Xospata is starting to bring in its first revenues – adding 2.5bn yen ($22m) to Astellas’

• 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