Treats relapsed or refractory CD22-positive B-cell … lymphoblastic leukemia (ALL). Sold as Besponsa. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Inotuzumab Ozogamicin (sold as Besponsa), first approved Aug 17, 2017, with 1 new use approved and 0 published complete response letters.
| Product | Part | Spending, 2025 | Change | Beneficiaries |
|---|---|---|---|---|
| Besponsa | Part B | $25.0M | +21% | 181 |
| Asciminib and Inotuzumab Ozogamicin for Relapsed or Refractory Philadelphia Chromosome-positive B-cell Acute Lymphoblastic Leukemia (R/R Ph+ B-ALL)B-cell Acute Lymphoblastic Leukemia (B-ALL) · Sunil G. Iyer | Phase 1 | Recruiting | Nov 13, 2026 |
| Venetoclax Plus Inotuzumab Reduced-Intensity Induction Sequentially Followed by Blinatumomab in B-ALLALL · Institute of Hematology & Blood Diseases Hospital, China | Not applicable | Not yet recruiting | Nov 6, 2026 |
| Inotuzumab as Post-Trasplantation Therapy for Adult High-risk B-cell Precursor Acute Lymphoblastic LeukemiaAcute Lymphobkastic Leukemia, Adult · PETHEMA Foundation | Phase 2 | Not yet recruiting | Oct 7, 2026 |
| Immunotargeted Therapy Plus Low-Dose Chemotherapy in Newly Diagnosed Adult Ph+ B-ALLPh+ Acute Lymphoblastic Leukemia (Ph+ALL) · Institute of Hematology & Blood Diseases Hospital, China | Phase 2 | Not yet recruiting | Sep 25, 2026 |
| A Study of Sonrotoclax (BGB-11417) in Children With Relapsed or Refractory Acute Myeloid Leukemia and B-cell Acute Lymphoblastic LeukemiaRelapsed Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia · BeOne Medicines | Phase 1 / Phase 2 | Not yet recruiting | Aug 18, 2026 |
| Immuno-Targeted Therapy Plus Low-Dose Chemotherapy for Newly Diagnosed Adult Ph-Negative B-ALL: A Prospective Umbrella TrialPh- Acute Lymphoblastic Leukemia (Ph-ALL) · Institute of Hematology & Blood Diseases Hospital, China | Phase 2 | Not yet recruiting | Jun 11, 2026 |
| Pediatric-Inspired Regimen Combined With Venetoclax and Immunotherapy for Adult Ph-Negative Acute Lymphoblastic LeukemiaAcute Lymphoblastic Leukemia, Adult · Institute of Hematology & Blood Diseases Hospital, China | Not applicable | Recruiting | Mar 27, 2026 |
| Chemotherapy With Targeted-Immunotherapy for Newly Diagnosed Ph+ ALLPh+ ALL · Institute of Hematology & Blood Diseases Hospital, China | Not applicable | Recruiting | Mar 25, 2026 |
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Aug 17, 2017 | BesponsaBLA 761040 · New molecular entity | Wyeth Pharms Inc | 1 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
