FDA Approves Inotuzumab Ozogamicin in Pediatric CD22+ ALL

Investigators assessed the efficacy of inotuzumab ozogamicin among 53 pediatric patients with relapsed/refractory CD22-positive B-cell precursor acute lymphoblastic leukemia as part of a multi-center, open-label, single-arm study.

The FDA has granted approval to inotuzumab ozogamicin (Besponsa) as a treatment for pediatric patients who are 1 year or older diagnosed with relapsed/refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL), according to a press release from the agency.

Investigators assessed the efficacy of the agent among 53 pediatric patients with this disease as part of a multi-center, open-label, single-arm study.

A complete response (CR) rate was reported in 42% (95% CI, 28.1%-55.9%) of patients, with a median duration of CR of 8.2 months (95% CI, 2.6-not evaluable [NE]). Among those with a CR, minimal residual disease (MRD) negativity was highlighted in 95.5% (95% CI, 77.2%-99.9%) per flow cytometry and in 86.4% (95% CI, 65.1%-97.1%) per reverse transcriptase polymerase chain reaction.

Common adverse effects (AEs) in the study included thrombocytopenia, anemia, vomiting, hemorrhage, neutropenia, nausea, leukopenia, febrile neutropenia, abdominal pain, and headache.

In the open-label study, investigators administered inotuzumab ozogamicin at 1.4 mg/m² per cycle in 12 patients and at 1.8 mg/m² per cycle in 41 patients. Patients also received premedication with methylprednisolone at 1 mg/kg plus an antipyretic and an antihistamine. The median number of treatment cycles was 2 (range, 1-4).

The study’s primary end points were the CR rate, duration of CR, and MRD negativity.

The regulatory agency recommended a starting dose of 1.8 mg/m² per cycle, given as 0.8 mg/m² on day 1, 0.5 mg/m² on day 8, and 0.5 mg/m² on day 15 of cycle 1.

Reference

FDA approves inotuzumab ozogamicin for pediatric patients with acute lymphoblastic leukemia. News release. FDA. March 6, 2024. Accessed March 6, 2024. https://tinyurl.com/573buabm