Obinutuzumab has been approved in Europe for a shorter, 90-minute infusion time among patients with previously untreated or previously treated follicular lymphoma, according to a press release from Roche, the drug’s manufacturer.

While the standard infusion time for obinutuzumab in this patient population is 3 to 4 hours, results of a recent clinical trial suggest that 90-minute infusions may be as effective, without increasing the rate of adverse events. The announcement, which is based on results from the open-label phase 4 GAZELLE trial (ClinicalTrials.gov Identifier: NCT03817853), suggests that patients may be able to spend less time in hospital, simultaneously improving quality of life and reducing health care system burden.

“[Obinutuzumab] has improved outcomes for people with follicular lymphoma, and now has the additional benefit of a shorter infusion time,” said Levi Garraway, MD, PhD, Roche’s chief medical officer and head of global product development, in a press release. “Reducing the amount of time patients need to be in hospital has the potential to improve their treatment experience whilst also increasing efficiency for institutions and healthcare systems.”


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GAZELLE, a multicenter single-arm study, permitted patients without grade 3 or worse adverse events on initial obinutuzumab infusion to receive the shorter infusion on cycle 2. Results from the study suggest that both efficacy and safety of the shorter infusion time were similar to those seen with the original, longer infusion time, with no new safety signals observed.

Obinutuzumab is an anti-CD20 monoclonal antibody that has previously received approval for use in both the US and Europe as part of a combination therapy in patients with chronic lymphocytic leukemia, and among some patients with follicular lymphoma.

Roche aims to update the drug’s label as soon as possible.

Reference

Roche’s Gazyvaro shorter 90-minute infusion time approved in Europe for people with previously treated or untreated follicular lymphoma. Basel, Switzerland: Roche; October 14, 2021.