14th Sep 2018 07:48
LONDON (Alliance News) - AstraZeneca PLC on Friday said its hairy cell leukaemia drug, Lumoxiti, has been approved by the US Food & Drug Administration.
Lumoxiti has been cleared for use in adult patients with relapsed or refracted forms of hairy cell leukaemia. This is a rare, chronic cancer which can cause serious and life-threatening problems. Between 30% and 40% of patients with the disease will relapse within five to 10 years of treatment.
Lumoxiti is the first FDA-approved medicine for this type of leukaemia in over 20 years, being approved under the regulator's priority review scheme. In phase three trials, 75% of patients given the drug showed an overall response while 30% had a durable response.
Robert Kreitman, the principal investigator of the phase III trial, said that the drug "represents a promising non-chemotherapeutic agent for hairy cell leukaemia, addressing an unmet medical need for physicians and their patients".
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