FDA oncological drugs advisory committee votes in support of Tecentriq in bladder cancer – Genentech/Roche
Genentech/Roche announced the FDA Oncologic Drugs Advisory Committee voted 10 to 1 in favor of maintaining accelerated approval of Tecentriq (atezolizumab) for the treatment of adults with locally advanced or metastatic urothelial carcinoma (mUC, bladder cancer) who are not eligible for cisplatin-containing chemotherapy and whose tumors express high levels of PD-L1 (PD-L1–stained tumor-infiltrating immune cells covering at least 5 percent of the tumor area) as determined by an FDA-approved test or are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status.
Tecentriq was granted accelerated approval in 2017 for the treatment of adults with locally advanced or mUC who are not eligible for cisplatin-containing chemotherapy based on the positive overall response rate and duration of response results from the IMvigor210 study. Tecentriq’s indication was subsequently focused on PD-L1 high patients, who would benefit the most based on findings from the IMvigor130 study in 2018. This Phase III trial is the designated PMR for the first-line mUC indication and met its co-primary endpoint of progression-free survival. IMvigor130 continues for overall survival (OS). Genentech looks forward to sharing the final OS results once available.