The FDA announced Friday the approval of Roche's Gazyva (obinutuzumab) for use in combination with chlorambucil to treat patients with previously untreated chronic lymphocytic leukaemia (CLL). The agency, which granted a priority review to the company's application, noted that Gazyva, previously known as GA101 and developed as a follow-on to MabThera (rituximab), is the first drug with breakthrough therapy designation to gain clearance.
Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, remarked "this approval reflects the promise of the Breakthrough Therapy Designation programme, allowing us to work collaboratively with companies to expedite the development, review and availability of important new drugs." Roche noted that Gazyva, which is part of a collaboration between Genentech and Biogen Idec in the US, will be available for patients within two weeks. Genentech spokeswoman Emmy Wang said the drug is estimated to cost $41 300 for a course of treatment.
The approval of Gazyva was supported by data from the Phase III CLL11 trial, which randomised 356 treatment-naïve patients with CLL to receive Gazyva in combination with chlorambucil or chlorambucil alone. In the study, Gazyva in combination with chlorambucil was associated with an 84-percent reduction in the risk of disease progression, while median progression-free survival in the Gazyva arm was 23 months, versus 11.1 months in the chlorambucil alone arm. Moreover, 27.8 percent of patients who received Gazyva plus chlorambucil achieved a complete response, compared to 0.9 percent of patients given chlorambucil alone.
Roche noted that final data from the CLL11 study comparing Gazyva plus chlorambucil to the combination of MabThera and chlorambucil will be presented in December at the American Society of Hematology annual meeting. Earlier this year, the company said a pre-planned interim analysis of the trial confirmed the superiority of Gazyva to MabThera, which is also marketed as Rituxan, following an earlier analysis demonstrating that Gazyva in combination with chlorambucil significantly reduced the risk of disease progression and death.
Marketing applications for Gazyva have also been submitted in other markets, including in Europe. The therapy is also being investigated in multiple head-to-head Phase III studies compared to MabThera in indolent non-Hodgkin lymphoma and diffuse large B-cell lymphoma. The monoclonal antibody is designed to attach to CD20 and attacks targeted cells both directly and together with the body's immune system.
For related analysis, see ViewPoints: Roche ticks another box in biosimilar defence/cancer domination strategy as FDA approves 'son of Rituxan' Gazyva and FirstWord Lists: FDA Breakthrough Therapy drugs.
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