EMA approves new shorter infusion time for Gazyvaro in follicular lymphoma.

The approval is based on a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP). The regular rate of infusion can take approximately three to four hours, so administering over a shorter time period can result in time savings for patients and could also reduce pressure on healthcare systems. This is especially important given the ongoing challenges for healthcare systems around the world brought about by the COVID-19 pandemic.

The approval is based on the phase IV GAZELLE study and other supportive studies investigating Gazyvaro in previously treated and untreated FL patients. The efficacy and safety of the GAZELLE study were consistent with that demonstrated by Gazyvaro administered at the regular rate of infusion. The trial showed that no patients experienced Grade 3 or higher infusion-related reactions during treatment cycle 2 with short duration infusion Gazyvaro, and no unexpected safety findings were found, supporting its use. Following this approval, Gazyvaro’s label update is being implemented immediately and Roche is aiming to launch short duration infusion Gazyvaro for patients in the EU with previously treated and untreated advanced FL as soon as possible. Gazyvaro is already approved for the treatment of FL, and now shorter duration infusion Gazyvaro will offer another more convenient option to enhance FL patients’ treatment experiences.