FL

Gazyvaro® (obinutuzumab) in combination with chemotherapy approved by the EMA for the treatment of newly diagnosed Follicular Lymphoma

On 22nd September 2017, the European Medicines Agency (EMA) approved Gazyvaro® (obinutuzumab) in combination with chemotherapy and followed by Gazyvaro® maintenance in patients achieving a response to treat newly diagnosed Follicular Lymphoma (FL).

The approval of Roche’s anti-CD20 monoclonal antibody is based on results of the phase III GALLIUM study (NCT01332968), the first trial in newly diagnosed FL to demonstrate superior PFS compared to rituximab based therapy, and follows a ‘positive opinion’ given by the EMA’s Committee for Medicinal Products for Human Use (CHMP) in July 2017 (read more here).

This is the third EMA approval for Gazyvaro®: in 2014 it was approved in combination with chlorambucil for patients newly diagnosed Chronic Lymphocytic Leukaemia (CLL) with comorbidities and unsuited to full-dose fludarabine-based therapy; and in June 2016, Gazyvaro® received approval in combination with bendamustine, followed by Gazyvaro® maintenance, in FL patients who did not respond or who progressed ≤6 months after receiving rituximab-based therapy.

References
  1. WebWire. Roche receives EU approval of Gazyvaro for people with previously untreated advanced follicular lymphoma. 2017 Sep 22. https://webwire.com/ViewPressRel.asp?aId=214026. [Accessed 2017 Sep 22].