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Besponsa (inotuzumab-ozogamicin)

Pfizer · FDA-approved active ADC Verified Quality 78/100

CD22-directed antibody-drug conjugate delivering cytotoxic calicheamicin to induce DNA breaks and apoptosis.

BESPONSA is a CD22-directed antibody-drug conjugate indicated for relapsed or refractory CD22-positive B-cell precursor ALL in patients 1 year and older. The drug demonstrates linear and time-dependent clearance with a 12.3-day half-life and achieves steady-state by Cycle 4 with 5.3-fold accumulation. Primary risks include QTc prolongation with concomitant QT-prolonging drugs and hepatic impairment considerations. The mechanism of intracellular calicheamicin release and DNA damage induction provides targeted cytotoxicity against CD22-expressing leukemic cells.

At a glance

Generic nameinotuzumab-ozogamicin
SponsorPfizer
Drug classAntibody-drug conjugate (ADC)
TargetCD22
ModalityADC
Therapeutic areaOncology
PhaseFDA-approved
First approval2017
Annual revenue200

Mechanism of action

Inotuzumab ozogamicin is a CD22-directed antibody drug conjugate where a monoclonal antibody recognizing human CD22 is covalently attached via a linker to N-acetyl-gamma-calicheamicin, a small molecule cytotoxic agent. Upon binding to CD22-expressing tumor cells, the ADC-CD22 complex is internalized and the linker undergoes hydrolytic cleavage, releasing N-acetyl-gamma-calicheamicin dimethylhydrazide intracellularly. The released calicheamicin is activated and induces double-strand DNA breaks, leading to cell cycle arrest and apoptotic cell death of the malignant cells.

Approved indications

Common side effects

Drug interactions

Patents

PatentExpiryType
Biologic Exclusivity

Primary sources

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SourceUsed for
FDA labelMechanism, indications, dosing, boxed warnings, drug interactions
FDA Orange BookPatents + exclusivity
SEC EDGARRevenue + earnings

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