EU CHMP recommends approval of Gazyvaro (obinutuzumab) for follicular lymphoma- Roche

The European Medicines Agency (EMA) has recommended extending the authorised indication of Gazyvaro (obinutuzumab), from Roche, to treat patients with follicular lymphoma. The medicine is to be used in combination with bendamustine in patients who were previously treated with chemotherapy. The recommendation from EMA�s Committee for Medicinal Products for Human Use (CHMP) is based on the results of a phase III trial that compared the effects of Gazyvaro given in combination with bendamustine and followed by Gazyvaro as a maintenance treatment, with the effects of bendamustine alone, in 321 patients with follicular lymphoma who did not respond to or whose disease progressed with chemotherapy.

In this study, patients treated with Gazyvaro in combination with bendamustine lived longer without their disease progressing compared to patients treated with bendamustine alone (on average about 29 months compared to 14 months). The most common side effects reported with the combination of Gazyvaro and bendamustine were consistent with the known safety profiles of the individual medicines.

Comment: Gazyvaro was first authorised in the European Union (EU) in July 2014 for use in combination with chlorambucil in patients with previously untreated chronic lymphocytic leukaemia.