BESPONSA
Besponsa (inotuzumab ozogamicin) is a CD22-directed antibody-drug conjugate indicated for the treatment of B-cell precursor acute lymphoblastic leukemia (ALL). It is specifically used for patients with CD22-positive disease that is either relapsed or refractory. This therapy is approved for use in both adult and pediatric patients aged one year and older.
How BESPONSA Works
This drug consists of a CD22-directed antibody linked to a cytotoxic agent called N-acetyl-gamma-calicheamicin. After the antibody binds to CD22-expressing tumor cells, the complex is internalized and the cytotoxic agent is released into the cell via hydrolytic cleavage. The released agent induces double-strand DNA breaks, which results in cell cycle arrest and apoptotic cell death.
Details
- Status
- Prescription
- First Approved
- 2017-08-17
- Routes
- N/A
- Dosage Forms
- POWDER, FOR INJECTION SOLUTION, LYOPHILIZED POWDER
BESPONSA Approval History
What BESPONSA Treats
1 indicationsBESPONSA is approved for 1 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Acute Lymphoblastic Leukemia
BESPONSA Boxed Warning
HEPATOTOXICITY, INCLUDING HEPATIC VENO-OCCLUSIVE DISEASE (VOD) (ALSO KNOWN AS SINUSOIDAL OBSTRUCTION SYNDROME) and INCREASED RISK OF POST-HEMATOPOIETIC STEM CELL TRANSPLANT (HSCT) NON-RELAPSE MORTALITY WARNING: HEPATOTOXICITY, INCLUDING HEPATIC VENO-OCCLUSIVE DISEASE (VOD) (ALSO KNOWN AS SINUSOIDAL OBSTRUCTION SYNDROME) and INCREASED RISK OF POST- HEMATOPOIETIC STEM CELL TRANSPLANT (HSCT) NON-RELAPSE MORTALITY See full prescribing information for complete boxed warning. • Hepatotoxicity, includi...
WARNING: HEPATOTOXICITY, INCLUDING HEPATIC VENO-OCCLUSIVE DISEASE (VOD) (ALSO KNOWN AS SINUSOIDAL OBSTRUCTION SYNDROME) and INCREASED RISK OF POST-HEMATOPOIETIC STEM CELL TRANSPLANT (HSCT) NON-RELAPSE MORTALITY WARNING: HEPATOTOXICITY, INCLUDING HEPATIC VENO-OCCLUSIVE DISEASE (VOD) (ALSO KNOWN AS SINUSOIDAL OBSTRUCTION SYNDROME) and INCREASED RISK OF POST- HEMATOPOIETIC STEM CELL TRANSPLANT (HSCT) NON-RELAPSE MORTALITY See full prescribing information for complete boxed warning. • Hepatotoxicity, including fatal and life-threatening VOD occurred in patients who received BESPONSA. ( 5.1 ) • A higher post-HSCT non-relapse mortality rate occurred in patients receiving BESPONSA ( 5.2 ) HEPATOTOXICITY, INCLUDING VOD • Hepatotoxicity, including fatal and life-threatening VOD occurred in patients with relapsed or refractory acute lymphoblastic leukemia (ALL) who received BESPONSA. The risk of VOD was greater in patients who underwent HSCT after BESPONSA treatment; use of HSCT conditioning regimens containing 2 alkylating agents and last total bilirubin level ≥ upper limit of normal (ULN) before HSCT were significantly associated with an increased risk of VOD. • Other risk factors for VOD in patients treated with BESPONSA included ongoing or prior liver disease, prior HSCT, increased age, later salvage lines, and a greater number of BESPONSA treatment cycles. • Elevation of liver tests may require dosing interruption, dose reduction, or permanent discontinuation of BESPONSA. Permanently discontinue treatment if VOD occurs. If severe VOD occurs, treat according to standard medical practice [see Dosage and Administration (2.3) and Warnings and Precautions (5.1) ]. INCREASED RISK OF POST-HSCT NON-RELAPSE MORTALITY • There was higher post-HSCT non-relapse mortality rate in patients receiving BESPONSA, resulting in a higher Day 100 post-HSCT mortality rate [see Warnings and Precautions (5.2) ] .
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Active Pipeline
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Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
BESPONSA FDA Label Details
ProIndications & Usage
FDA Label (PDF)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 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.
WARNING: HEPATOTOXICITY, INCLUDING HEPATIC VENO-OCCLUSIVE DISEASE (VOD) (ALSO KNOWN AS SINUSOIDAL OBSTRUCTION SYNDROME) and INCREASED RISK OF POST-HEMATOPOIETIC STEM CELL TRANSPLANT (HSCT) NON-RELAPSE MORTALITY WARNING: HEPATOTOXICITY, INCLUDING HEPATIC VENO-OCCLUSIVE DISEASE (VOD) (ALSO KNOWN AS SI...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.