Roche's Cancer Drug Candidate Shows Positive Results in Late Stage Trial

By Helena Smolak

Late-stage trial data for Roche's cancer drug Gazyva/Gazyvaro showed positive results in patients with kidney inflammation, increasing the likelihood of regulatory approval in Europe and the U.S.

Swiss pharma giant Roche said Thursday that it aims to bring the potential lupus nephritis treatment--which seeks to prevent or delay progression in end-stage kidney disease--to market as soon as possible after a study demonstrated treatment benefits compared to the standard of care.

The experimental drug candidate's late-stage trial showed a complete renal response among patients with lupus nephritis.

The data read-out over 76 weeks also met two key secondary goals--reduced corticosteroid use and improved proteinuric response--that were statistically significant, the company said. The safety profile was in line with the drug's profile and no new safety signals were identified, it said.

Gazyva/Gazyvaro was granted breakthrough therapy designation by FDA in 2019.

Write to Helena Smolak at helena.smolak@wsj.com

(END) Dow Jones Newswires

September 26, 2024 01:42 ET (05:42 GMT)

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