FDA Approves Inotuzumab Ozogamicin for Relapsed or Refractory B-Cell Precursor ALL

By The ASCO Post
Posted: 8/17/2017 2:22:47 PM
Last Updated: 8/17/2017 2:22:47 PM

On August 17, 2017, the U.S. Food and Drug Administration (FDA) approved inotuzumab ozogamicin (Besponsa) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

INO-VATE ALL

The approval was based on data from INO-VATE ALL, a randomized (1:1), open label, international, multicenter study in 326 patients with Philadelphia chromosome–negative or Philadelphia chromosome–positive relapsed or refractory B-cell precursor ALL. Patients were required to have ≥ 5% bone marrow blasts and to have received one or two previous induction chemotherapy regimens for ALL. Patients with Philadelphia chromosome–positive B cell precursor ALL were required to have disease that failed treatment with at least one tyrosine kinase inhibitor and standard chemotherapy.

Patients were randomized to receive inotuzumab ozogamicin (n = 164) or investigator’s choice of chemotherapy (n = 162). Of the initial 218 randomized patients, 35.8% of those who received inotuzumab ozogamicin experienced complete remission (CR) for a median 8.0 months and 89.7% of those patients achieved minimal residual disease (MRD)–negativity. Of the patients who received chemotherapy, 17.4% experienced CR for a median 4.9 months and 31.6% of those patients achieved minimal residual disease MRD-negativity.

The most common adverse reactions occurring in greater than 20% of patients were thrombocytopenia; neutropenia; infection; anemia; leukopenia; fatigue; hemorrhage; pyrexia; nausea; headache; febrile neutropenia; transaminases increased; abdominal pain; gamma-glutamyltransferase increased; and hyperbilirubinemia. The most common (≥ 2%) adverse reactions reported as the reason for permanent discontinuation were infection, thrombocytopenia, hyperbilirubinemia, transaminases increased, and hemorrhage.

For the first cycle, the recommended dose of inotuzumab ozogamicin for all patients is 1.8 mg/m² per cycle, administered as three divided doses on day 1 (0.8 mg/m²), day 8 (0.5 mg/m²), and day 15 (0.5 mg/m²). The recommended dosing for subsequent cycles depends on response to treatment.

FDA previously granted Orphan Drug and Breakthrough Therapy designations to inotuzumab ozogamicin for the treatment of ALL, as well as priority review.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.