Tecentriq atezolizumab regulatory update

FDA granted accelerated approval to Tecentriq atezolizumab from Roche’s Genentech unit to treat locally advanced or metastatic urothelial carcinoma that has progressed on or after platinum-based chemotherapy. Tecentriq is the first PD-L1 inhibitor to be approved by the agency and the first drug approved for metastatic bladder cancer in more than 30 years, according to Genentech.

Tecentriq’s approval was based on the single-arm Phase II IMvigor 210 trial. In January, Roche said median overall survival (OS) was 7.9 months in a cohort of 310 patients in the trial who had progressed after receiving platinum-based chemotherapy. On May 18, Genentech said it expects Tecentriq to be available for patients within 2 weeks. The company said the treatment will cost $12,500 per month; the median duration of Tecentriq has not yet been reached in IMvigor 210. ...