Inotuzumab ozogamicin (Besponsa)

General information

Class/mechanism: Antibody targeting CD22, conjugated with a cytotoxic, antitumor antibiotic (calicheamicin). Inotuzumab demonstrates a dose-dependent cytotoxicity both in vitro and in vivo.
Route: IV
Extravasation: No information

For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias or the prescribing information.

Diseases for which it is established

• B-cell acute lymphoblastic leukemia (FDA)
  • B-cell acute lymphoblastic leukemia, pediatric (FDA)

Diseases for which it is used

• Indolent lymphoma

Diseases for which it was used

• Diffuse large B-cell lymphoma

Patient drug information

• Inotuzumab ozogamicin (Besponsa) package insert
• Inotuzumab ozogamicin (Besponsa) patient drug information (Chemocare)

History of changes in FDA indication

• 2017-08-17: Approved for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). (Based on INO-VATE ALL)
• 2024-03-06: Approved for pediatric patients 1 year and older with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL).

History of changes in EMA indication

• 2017-06-28: Initial authorization

History of changes in Health Canada indication

• 2018-03-15: Initial notice of compliance as monotherapy for the treatment of adults with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL).

History of changes in PMDA indication

• 2018-01-19: New approval for the treatment of relapsed or refractory CD22-positive acute lymphoblastic leukemia.

Also known as

• Code name: CMC-544
• Brand name: Besponsa