FDA accepts Genentech’s sBLA for gazyva to treat untreated follicular lymphoma

The US Food and Drug Administration (FDA) has accepted biotechnology company Genentech’s supplemental biologics licence application (sBLA) and granted priority review for gazyva (obinutuzumab) for the treatment of untreated follicular lymphoma.

Genentech is a subsidiary of Swiss pharmaceutical company Roche.

Gazyva is an engineered monoclonal antibody designed to attach to CD20, a protein found on certain types of B-cells.

FDA has accepted the sBLA filing for gazyva in combination with chemotherapy followed by the treatment alone for patients with previously untreated follicular lymphoma, which is one of the most common types of blood cancer among adults.

Follicular lymphoma is a slow-growing (indolent) incurable form of non-Hodgkin’s lymphoma characterised by cycles of remission and relapse.

Genentech’s sBLA for gazyva is based on results obtained from the global, open-label, multicentre, randomised two-arm Phase III GALLIUM study that evaluates the efficacy and safety of gazyva together with chemotherapy, followed by the treatment alone for up to two years.

"Based on the GALLIUM study, Gazyva-based treatment significantly improved progression-free survival over the current standard of care, and we are committed to bringing this potential new option to patients as soon as possible."

GALLIUM is the first Phase III study in previously untreated follicular lymphoma to demonstrate superior progression-free survival (PFS) over rituxan (rituximab)-based treatment, which is the current standard-of-care.

Roche global product development chief medical officer and head Dr Sandra Horning said: "Follicular lymphoma becomes harder to treat each time it returns, and the goal of initial treatment is to prevent the cancer from progressing for as long as possible.

"Based on the GALLIUM study, Gazyva-based treatment significantly improved progression-free survival over the current standard of care, and we are committed to bringing this potential new option to patients as soon as possible."

Additional submissions of the GALLIUM trial data to health authorities worldwide are currently ongoing.