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FDA granted inotuzumab ozogamicin priority review and accepted its BLA for filing.
On Feb. 21, 2017, Pfizer announced that its biologics license application (BLA) for inotuzumab ozogamicin has been accepted for filing and granted priority review by FDA. Inotuzumab ozogamicin is being evaluated for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). Inotuzumab ozogamicin received breakthrough therapy designation from FDA in October 2015 for ALL. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by FDA is in August 2017. A marketing authorization application (MAA) for inotuzumab ozogamicin in the same patient population is currently under review by the European Medicines Agnecy.
The submissions are based on results from the Phase III INO-VATE 1022 trial, which enrolled 326 adult patients with relapsed or refractory B-cell ALL and compared inotuzumab ozogamicin to standard of care chemotherapy. The INO-VATE 1022 study had two independent primary endpoints, complete response with or without hematologic remission and overall survival. Results from the trial were published in The New England Journal of Medicine in June 2016.