FDA New Drug and Biologic Approvals -- 2017 Year-in-Review

Mary L Windle, PharmD

Disclosures

January 11, 2018

In This Article

Besponsa (inotuzumab ozogamicin)

Indication:

Relapsed or refractory B-cell precursor acute lymphoblastic leukemia.

Mechanism:

CD22-directed antibody-drug conjugate (ADC) recognizes human CD22; small molecule N-acetyl-gamma-calicheamicin is a cytotoxic agent that covalently attaches to antibody via a linker.

Dosage:

Total dose of inotuzumab is 1.8 mg/m² per 21-day cycle, administered as 3 divided doses on day 1 (0.8 mg/m²) and on days 8 and 15 (0.5 mg/m²). Dose for subsequent cycles is dependent on response following cycle 1.

Approval:

Approval was based on findings from the phase 3 INO-VATE trial, which compared inotuzumab with one of 3 standard chemotherapy regimens. The risk of progression or death was reduced by 55% with inotuzumab vs. standard therapy. Overall, a complete response (CR) or CR with incomplete hematologic recovery (CR/CRi) was experienced by 80.7% in the inotuzumab arm compared with 29.4% with chemotherapy.

Reference:

Kantarjian HM, et al. Inotuzumab ozogamicin versus standard therapy for acute lymphoblastic leukemia. N Engl J Med. 2016. 375:740-53.

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