"Breakthrough" status for Roche's Gazyva in lupus nephritis

The US Food and Drug Administration has granted Breakthrough Therapy designation (BTD) to Gazyva (obinutuzumab), a drug from Swiss pharma giant Roche (ROG: SIX), for adults with lupus nephritis.

This designation was granted based on data from the Phase II NOBILITY study in adult patients with proliferative lupus nephritis which showed Gazyva, in combination with standard of care (mycophenolate mofetil or mycophenolic acid and corticosteroids), demonstrated enhanced efficacy compared to placebo plus standard of care alone in achieving complete renal response at one year.

“New treatment options are needed for lupus nephritis, a potentially life-threatening inflammation of the kidneys that most commonly affects women,” said Dr Sandra Horning, Roche’s chief medical officer and head of global product development. “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.”

Gazyva was approved in 2013 for lymphoma and generated sales of around $393 million in 2018. There are currently no FDA-approved treatments for lupus nephritis, so such an added indication for the Roche candidate could improve its commercial success.