Treats relapsed or refractory CD22-positive B-cell … lymphoblastic leukemia (ALL). BLA 761040, held by Wyeth Pharms Inc. Inotuzumab Ozogamicin.
As of Nov 13, 2026, BLA 761040 (Besponsa), held by Wyeth Pharms Inc, was first approved by FDA on Aug 17, 2017, with 1 approved supplement and 0 published complete response letters.
1. INDICATIONS AND USAGE BESPONSA is indicated for the treatment of relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adult and pediatric patients 1 year and older. BESPONSA is a CD22-directed antibody and cytotoxic drug conjugate
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 6, 2024 | Supplement 3Efficacy (new indication or use) · Priority review | Approved | |
| Aug 17, 2017 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Besponsa0.9/MG/VIAL · powder, for injection solution, lyophilized powder | Inotuzumab Ozogamicin | Rx |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
