Gazyvaro® (obinutuzumab) plus chemotherapy given ‘positive opinion’ by EMA CHMP for newly diagnosed advanced Follicular Lymphoma

On the 21st July 2017, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) gave a ‘positive opinion’ of the anti-CD20 IgG1 monoclonal antibody Gazyvaro® (obinutuzumab) in patients with treatment naïve Follicular Lymphoma (FL).

The opinion was specifically for obinutuzumab combined with chemotherapy then followed by maintenance with obinutuzumab in patients who responded.

Results from the phase III, open-label, randomized GALLIUM study (NCT01332968) formed the basis of the committee’s positive opinion. Updated results for each immunochemotherapy regimen were presented by Wolfgang Hiddemann from the Ludwig-Maximilians University Hospital, Munich, Germany, during the 14th International Conference on Malignant Lymphoma (ICML) held last month in Lugano, Switzerland (read more here). Overall, a beneficial effect of obinutuzumab was observed with all chemotherapy backbones; the risk of disease progression or death decreased by 34% in FL patients who received obinutuzumab plus chemotherapy compared to those who received rituximab plus chemotherapy.

Furthermore, during the 22nd Congress of the European Hematology Association (EHA) held in Madrid, Spain, the Lymphoma Hub interviewed Associate Professor Judith Trotman from the Concord Repatriation General Hospital, Sydney, a member of our Scientific Advisory Board, on CT versus PET in the GALLIUM study (watch it here.)

Currently, obinutuzumab combined with bendamustine is approved by the EMA and the U.S. Food and Drug Administration (FDA) in patients with Relapsed/Refractory (R/R) FL.

  1. OncLive. Frontline Obinutuzumab Recommended for EU Approval for Follicular Lymphoma. 2017 Jul 21. http://www.onclive.com/web-exclusives/frontline-obinutuzumab-recommended-for-eu-approval-for-follicular-lymphoma. [Accessed 2017 Jul 21].