FDA approves Gazyva for new indication

Food and Drug Administration has 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), according to the drug’s marketer, Genentech, a subsidiary of Swiss pharma giant Roche (ROG: SIX).

The approval came on the same day that the FDA cleared Genentech/Roche’s new groundbreaking hemophilia A drug Hemlibra (emicizumab-kxwh), and adds to a like use approval by the European Commission in September, under the trade name Gazyvaro.

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 (NHL), is incurable and becomes harder to treat each time it returns.