Earlier today, the U.S. Food and Drug Administration (FDA) accepted Genentech’s supplemental Biologics License Application (sBLA) and granted Priority Review for the company’s follicular lymphoma treatment, Gazyva (obinutuzumab).
The drug was approved in February 2016
to treat follicular lymphoma who did not respond to Rituxan (rituximab)-containing regimen, or whose follicular lymphoma returned after treatment. The new priority review was granted for Gazyva in combination with chemotherapy, and is intended for people with previously untreated follicular lymphoma.
Follicular lymphoma develops from B lymphocytes, or B cells, and is the most common indolent type of non-Hodgkin lymphoma. Symptoms commonly include the enlargement of lymph nodes in the neck, underarms, abdomen, or groin, in addition to flu-like symptoms, like night sweats. Follicular lymphoma is characterized by cycles of remission and relapse.
The sBLA is based on results from the GALLIUM study
, which is the only Phase 3 study to date to find more significant progression-free survival in previously untreated follicular lymphoma than that found with Rituxan-based treatment, the current standard of care.
“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,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “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.”
In the GALLIUM study, 1,202 patients with previously untreated follicular lymphoma were evaluated with the primary endpoint being investigator-assessed progression-free survival (PFS) in patients with follicular lymphoma.
After a follow-up period of 41.1 months, it was found that Gazyva-based treatment reduced PFS by 32% compared to Rituxan-based treatment (P
Common Adverse Events (AEs) that occurred more often in the Gazyva arm than in the Rituxan arm included low white blood cell count, infections, infusion-related reactions, and new tumors.
Per the Virginia Cancer Institute, more than 14,000 new cases of follicular cancer will be diagnosed in 2017.
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