As Biosimilar Rituximab Competition Looms, Roche Gains Priority Review for Obinutuzumab

Genentech, a member of the Roche Group, announced on Sunday that the FDA has accepted the company’s supplemental Biologics License Application (sBLA) and granted a priority review for the company’s obinutuzumab (Gazyva) in combination with chemotherapy, followed by obinutuzumab alone, for patients who have previously untreated follicular lymphoma.
The Center for Biosimilars Staff
August 28, 2017
Genentech, a member of the Roche Group, announced on Sunday that the FDA has accepted the company’s supplemental Biologics License Application (sBLA) and granted a priority review for the company’s obinutuzumab (Gazyva) in combination with chemotherapy, followed by obinutuzumab alone, for patients who have previously untreated follicular lymphoma.

The sBLA for obinutuzumab is based on the GALLIUM study, which demonstrated that treatment with the drug significantly improved progression-free survival (PFS) over rituximab-based treatment, the current standard of care.

The study, a global, phase 3, open-label, multicenter, randomized, 2-arm study, provided a head-to-head comparison with rituximab (also Genentech’s drug) plus chemotherapy, followed by rituximab alone, for up to 2 years. The GALLIUM study included 1401 patients with previously untreated indolent non-Hodgkin’s lymphoma, 1202 of whom had follicular lymphoma. The study’s primary endpoint was PFS in patients with follicular lymphoma (assessed by an investigator). Secondary endpoints included PFS as assessed by an independent review committee.

Results after the follow-up period of 41.1 months showed that obinutuzumab-based treatment reduced the risk of disease worsening or death by 32% (investigator assessment) or 28% (independent review committee assessment) compared to rituximab-based treatment.

The most common grade 3 to 5 adverse events that occurred more often with obinutuzumab than with rituximab were the following:
  • Neutropenia (46.7% versus 39.5%)
  • Infections (20.3% versus 16.4%)
  • Infusion-related reactions (12.4% versus 6.7%)
  • Low platelet count (6.1% versus 2.7%)
  • New tumors (4.7% versus 2.7%)
  • Cardiac events (3.9% versus 2.8%)
The drug maker says that it expects the FDA to make a decision on approval of the proposed indication by December 23, 2017. Roche has been focusing on the development of innovator drugs as it faces looming biosimilar competition for market share of its top 3 cancer drugs, bevacizumab (Avastin), trastuzumab (Herceptin), and rituximab (Mabthera, Rituxan), which jointly earned Roche $22.1 billion in sales in 2016.

News of obinutuzumab’s priority review follows another such announcement from Genentech on Wednesday; last week, the drug maker announced that the FDA had accepted a BLA and granted priority review for its emicizumab, a novel biologic for the treatment of hemophilia A in patients who have factor VIII inhibitors.

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