AstraZeneca's leukaemia and breast cancer treatments make regulatory progress

AstraZeneca has reported regulatory progress in the US and Europe for treatments for a rare form of leukaemia and breast cancer.

The pharmaceutical company said the US Food and Drug Administration (FDA) had granted priority review to moxetumomab pasudotox – a potential new treatment for hairy cell leukaemia (HCL).

The immutoxin is intended for patients who have received at least two prior lines of therapy for HCL, a rare variety of leukaemia which affects about 1,000 people in the US each year. Though many patients respond initially to treatment up to 40% relapse.

“With no established standard of care and very few treatments available, there remains significant unmet medical need for people with relapsed or refractory HCL,” AstraZeneca said.

AstraZeneca also said the European Medicines Agency had approved its marketing authorisation application for Lynparza, a treatment for breast cancer devised with Merck of the US. Lynparza was approved by the FDA in January and is available in almost 60 countries.