Pfizer announces acceptance of regulatory submission for inotuzumab ozogamicin by the U.S. FDA

Pfizer

21 February 2017 - Application requests approval for the treatment of relapsed or refractory acute lymphoblastic leukaemia in adults.

Pfizer today announced that a biologics license application for inotuzumab ozogamicin has been accepted for filing and granted priority review by the U.S. FDA.

Inotuzumab ozogamicin is being evaluated for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia.

Read Pfizer press release

Michael Wonder

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Michael Wonder

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Medicine , US , Submission