FDA grants priority review to AstraZeneca's hairy cell leukaemia treatment
Source - SMW
AstraZeneca said Friday the US Food and Drug Administration had granted a priority review of the company's hairy cell leukaemia treatment.
The approval of the treatment, Lumoxiti, came after the drug, during a clinical trial, achieved its primary objective of clearing bone marrow of hairy cells and showing a haematologic remission in patients for a duration of more than 180 days.
'Today's FDA approval of Lumoxiti represents a significant milestone for people living with hairy cell leukaemia, a rare blood cancer that can result in serious and life-threatening conditions,' said Dave Fredrickson, Executive Vice-President, Global Head Oncology Business Unit.
'For patients, this approval provides the first FDA-approved medicine for this condition in more than 20 years.'