Drug updated on 5/17/2024
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.
Latest News
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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. The drug has been shown to induce a high rate of complete remission in treated populations, with significant adverse effects primarily hematologic.
- Two studies were reviewed for this summary. One study provided comprehensive analysis on Besponsa's efficacy and safety, while the other focused on exercise interventions for cancer patients without direct relevance to Besponsa.
- The first study showed that among ALL patients, complete remission rates stood at 67% with appreciable minimal residual disease response rates. For non-Hodgkin lymphoma (NHL) patients, pooled complete remission rate was reported as 28%.
- Safety concerns associated with Besponsa include common adverse effects such as thrombocytopenia and neutropenia. Venous obstructive disease/sinus obstructive syndrome occurred in 8% of patients; grade ≥3 thrombocytopenic events occurred in 29%, while grade ≥3 neutropenic events were observed in nearly half of the population studied.
- No direct comparison between Besponsa and other therapies within these studies was found, but it highlighted its potential effectiveness, alongside notable safety concerns, requiring careful management, especially among difficult-to-treat patient populations like those suffering from relapsed/refractory ALL or NHL.
- While specific subgroup considerations are not detailed within these summaries, supportive care interventions such as physical rehabilitation can be beneficial for overall health improvement, which could intersect with populations treated by this drug, according to the second document focusing outside of direct drug intervention.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Besponsa (inotuzumab ozogamicin) Prescribing Information. | 2024 | Pfizer Inc., Philadelphia, PA |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
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 |
---|---|---|
BC cancer protocol summary for treatment of relapsed or refractory pre-B cell acute lymphoblastic leukemia with inotuzumab ozogamicin. | 2022 | BC Cancer |
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 |