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AstraZeneca leukaemia drug receives US regulatory green light

In clinical trials, 75% of the people taking the drug responded to it. In 30% of cases, Lumoxiti had a “complete durable” effect
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The Food & Drug Administration has given the go ahead to Lumoxiti, which is used to treat a rare form of the disease

AstraZeneca’s (LON:AZN) biotechnology arm, MedImmune, has been given the regulatory green light for a treatment for hairy cell leukaemia.

Lumoxiti has been approved by the US Food & Drug Administration for relapsed patients, or those with a difficult-to-tackle form of the illness. It is the first new treatment option for the disease in the last two decades.

READ: AstraZeneca’s severe asthma treatment granted breakthrough therapy designation

In clinical trials, 75% of the people taking the drug responded to it. In 30% of cases, Lumoxiti had a “complete durable” effect.

"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, head of AZ’s oncology unit.

For patients, this approval provides the first FDA-approved medicine for this condition in more than 20 years."

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