NICE has recommended use of Astellas' Xospata (gilteritinib) for adults with relapsed or refractory FLT3 mutation-positive acute myeloid leukaemia (AML).
The backing, as outlined in a Final Appraisal Determination, is contingent on a commercial agreement being offered by the company and does not include its use as a maintenance therapy after haematopoietic stem cell transplant.
AML is a rare and aggressive cancer of the blood and bone marrow that, if untreated, can be fatal within a few months.
Around 3,100 people in the UK are diagnosed with AML each year, of which one-third will test positive for the FLT3 gene mutation, which can result in higher relapse rates and lower rates of survival than other forms of the disease.
The prognosis of patients with AML has remained poor despite advances in chemotherapy and little progress has been made that improves the long-term outcome for these patients.
NICE's recommendation of NHS funding for Xospata is based on data from the Phase III ADMIRAL trial, which showed that relapsed or refractory FLT3 mutation-positive AML patients who received the drug experienced significantly longer overall survival than those who received salvage chemotherapy.
Median overall survival for patients who received Xospata was 9.3 months, compared to 5.6 months for patients who received salvage chemotherapy, while rates of one-year survival were 37% and 17%, respectively.
“This marks a pivotal moment as, for the first time, adults in the UK with this specific form of AML have a much needed option at the point when current treatment no longer works or they relapse,” said Jackie Williams, general manager for Astellas in the UK. “We are proud to bring such an important treatment option that could significantly extend the lives of these patients.”