FDA grants priority review to AstraZeneca's hairy cell leukaemia treatment

  • Fri 14 Sep 2018 07:44

    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.'

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