A decision on the approval of obinutuzumab is expected by December 23, 2017.
The FDA granted Priority Review yesterday for obinutuzumab (Gazyva) in combination with chemotherapy followed by obinutuzumab alone for patients with previously untreated follicular lymphoma.
The accepted supplemental Biologics License Application (sBLA) is based on findings from the phase 3 GALLIUM study, according to a press release.
GALLIUM is an open-label, multicenter, randomized 2-arm study examining the safety and efficacy of obinutuzumab plus chemotherapy followed by obinutuzumab alone for up to 2 years, compared head-to-head against Rituxan plus chemotherapy followed by Rituxan alone for up to 2 years.
Included in the study were 1401 patients with previously untreated indolent non-Hodgkin’s lymphoma (iNHL), of whom 1202 patients had follicular lymphoma. Follicular lymphoma is a slow-growing form of non-Hodgkin’s lymphoma, and is one of the most common blood cancers among adults.
The primary endpoint was investigator-assessed progression-free survival (PFS) in patients with follicular lymphoma. Secondary endpoints included independent review committee-assessed PFS in the overall study population, overall response rate (ORR), complete response (CR), overall survival (OS), and safety.
The results of the study showed patients in the obinutuzumab arm experienced a reduced risk of disease worsening or death by 32% compared with patients in the Rituxan-based arm.
Independent review committee-assessed PFS was consistent with investigator-assessed PFS, according to the release. Obinutuzumab-based treatment reduced the risk of disease worsening or death by 28% compared with a Rituxan-based regimen. Currently, the median PFS has not been reached in either treatment arm.
The most common grade 3 to 5 adverse events were neutropenia, infections, infusion-related reactions, thrombocytopenia, second malignancies, and cardiac events.
“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,” Sandra Horning, MD, chief medical officer and head of Global Product Development at Genentech, said in the release. “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.”
The FDA is expected to decide on approval by December 23, 2017, according to the release.