FDA grants priority review for Gazyva (obinutuzumab) in combination with chemotherapy followed by Gazyva alone for people with previously untreated follicular lymphoma.-Genentech/Roche

Genentech, a member of the Roche Group announced that the FDA has accepted the company�s supplemental Biologics License Application (sBLA) and granted Priority Review for Gazyva (obinutuzumab) in combination with chemotherapy followed by Gazyva alone for people with previously untreated follicular lymphoma, one of the most common blood cancers among adults. Follicular lymphoma, a slow-growing (indolent) form of non-Hodgkin�s lymphoma, is incurable and characterized by cycles of remission and relapse.

The sBLA is based on results of the GALLIUM study, which is the first Phase III study in previously untreated follicular lymphoma to show superior progression-free survival (PFS) over Rituxan (rituximab)-based treatment, the current standard of care. Adverse events (AEs) with either Gazyva or Rituxan were consistent with those seen in previous studies.The FDA is expected to make a decision on approval under Priority Review by December 23, 2017.

Comment: Gazyva (obinutuzumab) is a prescription medicine used: 1. With the chemotherapy drug, chlorambucil, to treat chronic lymphocytic leukemia (CLL) in adults who have not had previous CLL treatment. 2. With the chemotherapy drug, bendamustine, followed by Gazyva alone for follicular lymphoma (FL) in adults who did not respond to a rituximab-containing regimen, or whose FL returned after such treatment.