Japanese pharma Astellas has won a positive recommendation from the EMA’s Committee for Medical Products for Human Use (CHMP) for Xospata (gilteritinib), setting up a likely approval in the EU in the near future.
The FLT3 inhibitor received the positive opinion for use as a monotherapy in the treatment of relapsed or refractory acute myeloid leukemia (AML) with FLT3 mutation. The decision is based on the results from Astellas’ phase 3 ADMIRAL trial investigating Xospata compared to salvage chemotherapy.
According to the results from this study, patients being treated with Xospata achieved significantly longer overall survival (OS) when compared to the placebo arm. Those patients receiving the FLT3 inhibitor achieved a median OS of 9.3 months, versus 5.6 months for those on the salvage chemotherapy arm.
The one-year rates of survival were also improved in those being treated with Xospata, with 37% of patients receiving the drug reaching this endpoint compared to 17% of those being treated with salvage chemotherapy.
Astellas scored FDA approval for Xospata last year, making it the first drug in the FLT3 inhibitor class to be approved for use in relapsed or refractory AML with a FLT3 inhibitor mutation. It was the second drug in the class to be approved in the US after Novartis’ Rydapt (midostaurin), which was approved for newly-diagnosed FLT3-positive AML by the FDA in 2017.
AML is the most common form of acute leukaemia in adults and has a low survival rate. One in four patients with this blood cancer reach five years of survival following diagnosis and approximately 10,000 people in the US die each year from the disease. FLT3 mutations are seen in around a third of all patients and are associated with a poorer prognosis.
“There is a high unmet need in AML and Astellas is committed to improving treatment options. Xospata offers a potential new alternative for patients with relapsed or refractory FLT3-positive AML, with data showing improved survival outcomes,” said Andrew Krivoshik, senior vice president and global therapeutic area head, oncology development, Astellas.
The positive recommendation puts Astellas even further in the lead in front of Daiichi Sankyo – its candidate for FLT3-positive AML was rejected by the FDA earlier this year following misgivings regarding the design of the study. Another potential rival comes from Arog Pharma, with its candidate crenolanib being studied in a phase 3 trial in FLT3-positive AML.
Astellas has already started to see the first revenues from Xospata, with the drug bringing in 2.5bn yen ($22m) in the first quarter. The company is predicting that by the end of the year, revenues from Xospata will reach more than 15bn yen ($137m).
The drug is currently being investigated in additional FLT3-positive AML patient populations in several phase 3 trials, with potential hopes to extend into the first-line setting and challenge Rydapt.