> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Priority Review for Pfizer Leukemia BLA
- URL: https://www.fdaweb.com/fda-priority-review-for-pfizer-leukemia-bla/
- Published: 2017-02-21T12:00:00.000Z
- Updated: 2026-09-14T22:07:36.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5138022

FDA has accepted for priority review a Pfizer BLA for inotuzumab ozogamicin for treating adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). Inotuzumab ozogamicin received a Breakthrough Therapy designation from the agency 10/2015\. The user fee review target date is expected in August.

  
The submission is based on data from the company’s Phase 3 INO-VATE 1022 trial, which enrolled 326 adult patients with relapsed or refractory B-cell ALL and compared the therapy to standard of care chemotherapy. The study had two independent primary endpoints, complete response with or without hematologic remission and overall survival (OS). The trial met its first primary endpoint of complete response, which was significantly better with inotuzumab ozogamicin compared to chemotherapy (80.7% vs. 29.4%), according to the company. “The second primary endpoint of OS showed a strong trend toward longer OS for patients treated with inotuzumab ozogamicin compared to chemotherapy, but did not reach the level of statistical significance (p < 0.0104) for the trial...,” it says.