FDA Accepts sBLA, Grants Priority Review for Obinutuzumab in Previously Untreated Follicular Lymphoma

On August 28, the U.S. Food and Drug Administration (FDA) accepted the supplemental Biologics License Application (sBLA) and granted Priority Review for obinutuzumab (Gazyva) in combination with chemotherapy followed by obinutuzumab alone for patients with previously untreated follicular lymphoma. Follicular lymphoma, an indolent form of non-Hodgkin lymphoma, is incurable and characterized by cycles of remission and relapse.

“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, MD, Chief Medical Officer and Head of Global Product Development at Roche. “Based on the GALLIUM study, obinutuzumab-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 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 over rituximab (Rituxan)-based treatment, the current standard of care. Adverse events with either obinutuzumab or rituximab 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. Additional submissions of the GALLIUM data to health authorities around the world are ongoing. 

More About the GALLIUM Study

GALLIUM is a global phase III open-label, multicenter, randomized two-arm study examining the efficacy and safety of obinutuzumab plus chemotherapy followed by obinutuzumab alone for up to 2 years, as compared head-to-head against rituximab plus chemotherapy followed by rituximab alone for up to 2 years. Chemotherapies used were cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP); cyclophosphamide, vincristine, prednisone (CVP); or bendamustine (Treanda) and were selected by each participating study site prior to beginning enrollment.

GALLIUM included 1,401 patients with previously untreated indolent non-Hodgkin lymphoma (NHL), 1,202 of whom had follicular lymphoma. The primary endpoint of the study was investigator-assessed progression-free survival in patients with follicular lymphoma, with secondary endpoints including progression-free survival assessed by independent review committee (IRC) in patients with follicular lymphoma, progression-free survival in the overall study population (indolent NHL), response rate (overall response and complete response), overall survival, and safety.

Results after a follow-up period of 41.1 months showed:

  • Obinutuzumab-based treatment reduced the risk of disease worsening or death (progression-free survival, as assessed by investigator) by 32% compared to rituximab-based treatment (hazard ratio [HR] = 0.68; 95% confidence interval [CI] = 0.54–0.87; P = .0016).
  • IRC-assessed progression-free survival was consistent with investigator-assessed progression-free survival. As assessed by IRC, obinutuzumab-based treatment reduced the risk of disease worsening or death by 28% compared to rituximab-based treatment (HR = 0.72; 95% CI = 0.56–0.93; P = .0018). Median progression-free survival has not yet been reached in either treatment arm.
  • The most common Grade 3–5 adverse events that occurred more often in the obinutuzumab arm compared to the rituximab arm were low white blood cell count (neutropenia, 46.7% vs 39.5%), infections (20.3% vs 16.4%), infusion-related reactions (12.4% vs 6.7%), low platelet count (thrombocytopenia, 6.1% vs 2.7%), second malignancies (4.7% vs 2.7%), and cardiac events (3.9% vs 2.8%).

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.




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