Astellas AML treatment receives fast track designation from FDA
Astellas Pharma has received fast-track designation in the US for its FLT3 inhibitor, Gilteritinib, a drug that could potentially rival Novartis’ budding $250m-plus product Rydapt (Midostaurin).
The FDA gave the status to Gilteritinib as a treatment for adults with FLT3-mutation-positive relapsed or refractory acute myeloid leukaemia (AML), a cancer that impacts blood and bone marrow.
Steven Benner, Senior Vice President and Global Therapeutic Area Head, Oncology Development, Astellas, said: “Mutations of FLT3 in AML are associated with a poor prognosis and we are committed to working with the FDA to meet the requirements of the expedited review process.”
The new designation means the Japanese pharma firm will hold more meetings with the FDA, with the potential of priority review if supported by clinical data.
Benner concluded: “We are pleased that the FDA has acknowledged the urgent need for new therapies for FLT3+ AML patients.”
According to the American Cancer Society, 21,000 US-based patients were diagnosed with AML in 2016 alone and, of that number, 10,000 cases resulted in death.
Astellas has four late-stage Gilteritinib trials currently ongoing and the firm said its investigational compound has also demonstrated inhibition of AXL, which is reported to be associated with therapeutic resistance.
If approved, the Japanese pharma group would see its drug not only compete with Rydapt – the first new drug for AML in more than 25 years – but also with Daiichi Sankyo’s Quizartinib and Arog Pharma’s Crenolanib as well.