FDA Approves Inotuzumab Ozogamicin for Patients With Relapsed/Refractory B-Cell Precursor ALL

The U.S. Food and Drug Administration (FDA) approved inotuzumab ozogamicin, an anti-CD22 monoclonal antibody, for adults with relapsed/refractory B-cell precursor acute lymphocytic leukemia (ALL).

The drug’s approval was based on results from the randomized, phase III INO-VATE 1022 trial, which included 326 patients who had previously received one or two ALL treatments. Patients were randomized to receive inotuzumab ozogamicin (n=164) or an alternative chemotherapy regimen (n=162). Of the 218 evaluable patients, 35.8 percent in the inotuzumab ozogamicin cohort achieved a complete remission (CR) for a median of 8.0 months, compared with 17.4 percent who experienced CR for a median of 4.9 months in the alternative chemotherapy cohort.

The most common adverse events (AEs; occurring in >20% of patients) related to inotuzumab ozogamicin included thrombocytopenia, neutropenia, leukopenia, infection, anemia, fatigue, hemorrhage, pyrexia, nausea, headache, febrile neutropenia, increased transaminases and/or gamma-glutamyl transferase, abdominal pain, and hyperbilirubinemia. Serious AEs included myelosuppression, infusion-related reactions, and prolonged QT interval.

The drug carries a boxed warning for the risk of severe hepatotoxicity, including veno-occlusive disease and sinusoidal obstruction syndrome. The boxed warning also includes an increased risk of death for patients who take inotuzumab ozogamicin after receiving a hematopoietic cell transplantation.

The FDA previously granted inotuzumab ozogamicin priority review and breakthrough-therapy designation.

Source: U.S. Food and Drug Administration news release, August 17, 2017.