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gilteritinib

This page shows the latest gilteritinib news and features for those working in and with pharma, biotech and healthcare.

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

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FDA fast-tracks Astellas' Rydapt rival

Astellas Pharma has claimed a fast-track designation in the US for its FLT3 inhibitor gilteritinib, a drug that could rival Novartis’ budding $250m-plus product Rydapt (midostaurin). ... The FDA gave the status to gilteritinib as a treatment for adults
Astellas extends phase III programme for Rydapt rival gilteritinib

Astellas has started a fourth phase III trial of acute myeloid leukaemia (AML) drug gilteritinib, a FLT3 inhibitor racing to join Novartis' recently-approved Rydapt on the market. ... Given this reality, it is exciting to study gilteritinib in patients
Novartis' Rydapt approval ends long AML therapy drought

Meanwhile Astellas' gilteritinib - billed as a second-generation FLT3 inhibitor that avoids a resistance mechanism seen with earlier drugs - is also in late-stage testing.

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