Inotuzumab ozogamicin received U.S. Food and Drug Administration (FDA) approval for the treatment of relapsed or refractory (R/R) CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL) in pediatric patients 1 year and older.
Approval was granted based on the results of a multicenter, single-arm, open-label study. Results found that 42% of patients achieved complete remission with a median duration of 8.2 months.
The trial also found several common adverse reactions to the medication, including abdominal pain, anemia, febrile neutropenia, headache, hemorrhage, increased transaminases, infection, leukopenia, nausea, neutropenia, pyrexia, thrombocytopenia, and vomiting.
Prior to approval, inotuzumab ozogamicin received priority review and orphan drug designation. The treatment was also approved in 2017 to treat R/R B-cell precursor ALL in adult patients.
Source: FDA, March 6, 2024.
