Roche's Gazyva nabs FDA breakthrough therapy status for lupus nephritis

Roche said Wednesday that the FDA granted breakthrough therapy designation to the anti-CD20 monoclonal antibody Gazyva (obinutuzumab) for adults with lupus nephritis. The drugmaker noted that there are currently no medicines approved for the condition in the US.

According to Roche, the designation was based on data from the Phase II NOBILITY study, which the drugmaker reported in June met its primary endpoint and key secondary goals. Results showed that Gazyva, in combination with standard of care, was associated with enhanced efficacy compared to placebo plus standard of care alone in achieving complete renal response at one year.

"We are committed to developing Gazyva as a potential new therapy for lupus nephritis and plan to begin enrolling patients in a Phase III trial next year," remarked Sandra Horning, Roche's head of global product development. The company has previously investigated other anti-CD20 monoclonal antibodies, namely Rituxan (rituximab) and Ocrevus (ocrelizumab), in lupus nephritis. However, Rituxan failed to meet the main goal of a late-stage trial in this indication in 2009, while the development of Ocrevus in lupus nephritis was halted due to safety concerns.

Gazyva, which is part of a collaboration between Roche's Genentech unit and Biogen in the US, was first approved by the FDA in 2013 for use in combination with chlorambucil to treat patients with previously untreated chronic lymphocytic leukaemia, gaining clearance the following year in the EU, where it is sold as Gazyvaro. The product is also authorised for use in certain patients with follicular lymphoma and generated sales of CHF 390 million ($392 million) in 2018.

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