Supplemental BLA for Gazyva® (obinutuzumab) for frontline Follicular Lymphoma granted Priority Review by the FDA

On 28th August 2017, the U.S. Food and Drug Administration (FDA) accepted the Supplemental Biologics License Application (sBLA) submitted by Genentech for Gazyva® (obinutuzumab) in combination with chemotherapy, followed by obinutuzumab alone, for patients with newly diagnosed Follicular Lymphoma (FL). Furthermore, the FDA has granted Priority Review of this application with a target action date of 23rd December 2017.

The sBLA is based on data from the phase III GALLIUM trial (NCT01332968), which aimed to assess the benefit of obinutuzumab plus chemotherapy versus rituximab plus chemotherapy followed by obinutuzumab or rituximab maintenance in responders with previously untreated Indolent Non-Hodgkin Lymphoma (iNHL).

The Lymphoma Hub reported on the primary results of the GALLIUM trial, which were presented during the 58th Annual Meeting & Exposition of the American Society of Hematology (ASH) in San Diego, CA (read here). An oral abstract which focused on the incidence of Minimal Residual Disease (MRD) in the trial was also presented (read more here). Furthermore, while at ASH 2016, we also interviewed Professor Sonali Smith and Professor Anton Hagenbeek on the GALLIUM study (click the links to view).

More recently, during the 14th International Conference on Malignant Lymphoma (ICML), updated results of the GALLIUM trial were presented by Wolfgang Hiddemann from the Ludwig-Maximilians University Hospital Munich, Germany (abstract 107); read our report here. Furthermore, while we were at the 22nd Conference of the European Hematology Association (EHA), we spoke with Associate Professor Judith Trotman from Concord Repatriation General Hospital, Sydney, Australia, comparing the use of CT and PET in the GALLIUM study (watch here).

  1. OncLive®. FDA Grants Frontline Obinutuzumab Priority Review for Follicular Lymphoma. 2017 Aug 28. http://www.onclive.com/web-exclusives/fda-grants-frontline-obinutuzumab-priority-review-for-follicular-lymphoma. [Accessed 2017 Aug 29].