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Besponsa Approved for Certain Type of ALL
FDA news release; 2017 Aug 17
The FDA has approved Besponsa (inotuzumab ozogamicin) for the treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
Indications: Besponsa is a CD22-directed antibody-drug conjugate indicated for the treatment of adults with relapsed or refractory B-cell precursor ALL.
Dosage and administration:
Cycle 1 (21 days):
- Day 1: 0.8 mg/m2
- Days 8 and 15: 0.5 mg/m2
For subsequent cycles (28 days) in patients achieving complete remission (CR) or complete remission with incomplete marrow recovery (CRi):
- Days 1, 8, and 15: 0.5 mg/m2
For subsequent cycles (28 days) in patients not achieving CR or CRi:
- Day 1: 0.8 mg/m2
- Days 8 and 15: 0.5 mg/m2
Efficacy and safety: Approval is based on a randomized trial showing that 36% of those who received Besponsa experienced CR for a median 8.0 months; 90% of those patients achieved minimal residual disease-negativity.
Side effects/risks: The most common adverse reactions are thrombocytopenia, neutropenia, infection, anemia, leukopenia, fatigue, hemorrhage, pyrexia, nausea, headache, febrile neutropenia, transaminases increased, abdominal pain, gamma-glutamyltransferase increased, and hyperbilirubinemia.
FDA approves inotuzumab ozogamicin for relapsed or refractory B-cell precursor ALL [news release]. Silver Spring, MD: FDA. August 17, 2017. https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm572133.htm. Accessed August 21, 2017.
Besponsa [package insert]. Philadelphia, PA: Wyeth Pharmaceuticals, Inc. 2017. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761040s000lbl.pdf. Accessed August 21, 2017.