Inotuzumab ozogamicin

(Besponsa®)

Inotuzumab ozogamicin

Drug updated on 5/17/2024

Dosage Forminjectable (intravenous; 0.9 mg/vial)
Drug ClassCD22-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
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  • 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.