The U.S. Food and Drug Administration (FDA) approved inotuzumab ozogamicin, an anti-CD22 monoclonal antibody, for the treatment of adults with relapsed/refractory B-cell precursor acute lymphocytic leukemia (ALL). Earlier this year, the FDA granted the drug priority review, as well as orphan-drug and breakthrough-therapy designations.
Approval was based on data from the INO-VATE ALL trial, in which patients with Philadelphia chromosome–positive or –negative relapsed or refractory B-cell precursor ALL were randomized to receive either inotuzumab ozogamicin (n=164) or investigator’s choice of chemotherapy (n=162). In the inotuzumab arm, 35.8 percent of patients achieved complete remission (CR), lasting for a median of eight months (range not provided). Also, 89.7 percent of responders were negative for minimal residual disease (MRD). In the investigator-choice arm, only 17.4 percent of patients achieved CR, lasting a median of 4.9 months (range not provided), and 31.6 percent were MRD negative.
The most common adverse reactions (occurring in >20% of patients) were thrombocytopenia, neutropenia, infection, anemia, leukopenia, fatigue, hemorrhage, pyrexia, nausea, headache, febrile neutropenia, increased transaminases, abdominal pain, increased gamma-glutamyltransferase, and hyperbilirubinemia.
The drug will carry a box warning for risk of hepatotoxicity, including hepatic veno-occlusive disease, and an increased risk of death for patients who use the drug after a hematopoietic stem cell transplantation.
Sources: FDA press release, August 17, 2017; Reuters, August 17, 2017.