The Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Gazyva (obinutuzumab) to include a new dosing regimen for patients with follicular lymphoma (FL) who have completed 3 administrations of Gazyva at the standard rate without grade 3 or higher infusion-related reactions (IRRs).
For patients with FL who do not experience a grade 3 or higher IRR during Cycle 1, Gazyva may now be administered as a 90-minute infusion, consisting of 100mg/hr for 30 minutes, then 900mg/hr for approximately 60 minutes. If an IRR of grade 1 or 2 with ongoing symptoms or a grade 3 or higher IRR occurs during the previous 90-minute infusion, all subsequent Gazyva infusions should be administered at the standard infusion rate.
The safety of Gazyva administered as a shortened-duration infusion was evaluated in the single-arm GAZELLE study (ClinicalTrials.gov Identifier: NCT03817853). During Cycle 1, all patients received Gazyva at the standard infusion rate with premedication. If no grade 3 or higher IRR occurred with any infusion in Cycle 1, Gazyva was administered over approximately 90 minutes in Cycle 2 and subsequent cycles. The percentage of grade 3 or higher IRRs during Cycle 2 was designated as the primary safety outcome.
Of the 113 patients treated with Gazyva, 99 (88%) received the 90-minute infusion starting in Cycle 2. Of these patients, 10% experienced IRRs of any grade in Cycle 2, with 8% and 2% of patients having a grade 1 IRR or grade 2 IRR, respectively. Following Cycle 2, 1 patient experienced a grade 3 IRR, which occurred after the 90-minute infusion at Cycle 5.
Gazyva is supplied as a 40mL single-dose vial containing 1000mg of obinutuzumab.
Gazyva. Package insert. Genentech, Inc.; 2021. Accessed February 15, 2022. https://www.gene.com/download/pdf/gazyva_prescribing.pdf.