NEW YORK – China's National Medical Products Administration (NMPA) on Wednesday granted conditional approval for Astellas' gilteritinib (Xospata) to treat FLT3-mutated, relapsed or refractory acute myeloid leukemia.
The NMPA conditional approval was based on results from the Phase III ADMIRAL trial. In that study, patients taking gilteritinib had a median overall survival of 9.3 months, compared to 5.6 months for those on salvage chemotherapy. The regulator also reviewed data from the Phase III COMMODORE trial studying gilteritinib against chemotherapy in Chinese FLT3-mutated AML patients.
Gilteritinib has shown activity in AML patients with two types of FLT3 mutations: FLT3 internal tandem duplications (FLT3-ITD) and FLT3 tyrosine kinase domain (FLT3-TKD) mutations. FLT3-ITD mutations occur in about 30 percent of AML patients and FLT3-TKD mutations impact approximately 7 percent.
"There is an urgent unmet need among FLT3-mutated relapsed or refractory AML patients, whose median survival is currently less than six months with chemotherapy," Andrew Krivoshik, global therapeutic area head for oncology development at Astellas, said in a statement. "The expedited approval of gilteritinib is an important step in offering a new treatment option for doctors and patients in China."
China's NMPA accepted gilteritinib for this indication for priority review in July 2020. Gilteritinib is the first targeted therapy for FLT3-mutated AML to be approved in China. The drug is already approved in this indication in the US, UK, and Europe.
Astellas was also exploring the drug in a Phase III study in newly diagnosed, FLT3-mutated AML patients, but had to terminate the trial after gilteritinib failed to improve survival compared to treatment with azacytidine.