FDA Approves New Option for ALL
The US Food and Drug Administration has approved inotuzumab ozogamicin (Besponsa) for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
All patients initiating inotuzumab ozogamicin are recommended to receive a 1.8 mg/m2 dose for the first cycle, which is divided into 3 doses: 0.8 mg/m2 on day 1, 0.5 mg/m2 on day 8, and 0.5 mg/m2 on day 15. Additional dosing recommendations for subsequent cycles are dependent on the patient’s response to treatment.
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Approval for inotuzumab ozogamicin was based on data from a randomized open-label, international study that included 326 patients with Philadelphia chromosome-negative or Philadelphia chromosome-positive relapsed or refractory B-cell precursor ALL. Of the 216 patients who had initially received inotuzumab ozogamicin, 35.8% had experienced complete remission (CR) for a median 8 months, and 89.7% had achieved minimal residual disease (MRD)-negativity compared with patients who had received the investigator’s choice of chemotherapy (CR, 17.4% for median 4.9 months; MRD-negativity, 31.6%)
Common adverse events associated with inotuzumab ozogamicin included thrombocytopenia, neutropenia, infection, anemia, and more. Among the most common reasons patients permanently discontinued treatment were infection, thrombocytopenia, hyperbilirubinemia, transaminases increases, and hemorrhage.
FDA approves inotuzumab ozogamicin for relapsed or refractory B-cell precursor ALL [press release]. Silver Spring, MD: US Food and Drug Administration; August 17, 2017. https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm572133.htm. Accessed August 17, 2017.