The National Institute for Health and Care Excellence has now published final guidance backing NHS use of Astellas' Xospata as monotherapy for adults with relapsed or refractory FLT3 mutation-positive acute myeloid leukaemia (AML).

The endorsement remains contingent on the confidential commercial agreement agreed with the company, and does not include its use as a maintenance therapy after haematopoietic stem cell transplant.

Each year around 3,100 people in the UK are diagnosed with AML, a rare and aggressive cancer of the blood and bone marrow that, if untreated, can be fatal within a few months.

Around 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.

Data from the Phase III ADMIRAL trial 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.