Drug updated on 4/18/2024
| Dosage Form | injectable (intravenous; 0.9 mg/vial) |
| Drug Class | CD22-directed antibody drug conjugates |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) in adult and pediatric patients 1 year and older.
Summary
- Inotuzumab ozogamicin (Besponsa) is indicated for the treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) in adult and pediatric patients 1 year and older, with potential application in non-Hodgkin lymphoma (NHL).
- A study focused on the application of Besponsa included an analysis based on systematic review/meta-analysis.
- This drug has been evaluated across a broad demographic, including both ALL and NHL patients, as per results from 12 studies comprising 644 patients.
- For ALL, Besponsa showed high complete remission rates at 67% and minimal residual disease response rates at 45%. For NHL, the complete remission rate was noted to be 28%.
- The safety profile indicates a significant occurrence of adverse events, including thrombocytopenia with an incidence rate of 29%, neutropenia with an incidence rate of 48%, and venous obstructive disease/sinus obstructive syndrome reported in about 8% of treated individuals.
- Compared to other therapeutic agents used for similar conditions, Besponsa's safety profile is characterized by notable risk factors that require careful consideration, including hematologic and hepatic adverse events.
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| BC cancer protocol summary for treatment of relapsed or refractory pre-B cell acute lymphoblastic leukemia with inotuzumab ozogamicin. | 2022 | BC Cancer |
| Efficacy and safety of inotuzumab ozogamicin (CMC-544) for the treatment of relapsed/ refractory acute lymphoblastic leukemia and non-Hodgkin lymphoma: a systematic review and meta-analysis. | 2021 | Clinical Lymphoma, Myeloma & Leukemia |
| Efficacy of targeted immunotherapy as induction or salvage therapy in acute lymphoblastic leukemia: a systematic review and meta-analysis. | 2021 | Technology in Cancer Research & Treatment |
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| The Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immunotherapy for the treatment of acute leukemia. | 2020 | Journal for ImmunoTherapy of Cancer |
| Pediatric acute lymphoblastic leukemia, version 2.2020. | 2020 | Journal of the National Comprehensive Cancer Network |
| Princess Margraret Cancer Centre clinical practice guidelines. | 2019 | Princess Margaret Cancer Centre |