Posted by Michael Wonder on 16 Nov 2017
FDA approves Genentech’s Gazyva for previously untreated advanced follicular lymphoma
16 November 2017 - The first treatment option to demonstrate superior progression-free survival over standard-of-care Rituxan-based therapy.
Genentech announced today that the U.S. FDA approved Gazyva (obinutuzumab) in combination with chemotherapy, followed by Gazyva alone in those who responded, for people with previously untreated advanced follicular lymphoma (stage II bulky, III or IV).
The approval is based on results from the Phase III GALLIUM study, which showed superior progression-free survival (PFS) for patients who received this Gazyva-based regimen compared with those who received a Rituxan (rituximab)-based regimen as an initial (first-line) therapy. Follicular lymphoma, the most common slow-growing (indolent) form of non-Hodgkin’s lymphoma, is incurable and becomes harder to treat each time it returns.
