AstraZeneca (LON:AZN) has announced that the US Food and Drug Administration has approved its cell leukaemia treatment.
Hairy cell leukaemia (HCL) is a rare, chronic and slow-growing leukaemia where bone marrow overproduces abnormal B cell lymphocytes. This can result in life-threatening conditions such as infections, bleeding and anaemia. HCL is diagnosed in roughly 1,000 people in the US each year.
The treatment, named Lumoxiti, has been approved following a successful clinical trial. Fundamentally, the treatment successfully cleared bone marrow of hairy cells. Moreover, it has shown a haematologic remission in patients for a duration of more than 180 days.
75% of patients receiving Lumoxiti achieved an overall response. Additionally, 30% had a durable complete response.
Dave Fredrickson, Executive Vice-President, commented:
“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. For patients, this approval provides the first FDA-approved medicine for this condition in more than 20 years.”
At 14:27 BST today, shares in AstraZeneca dropped by 0.28%.