28 April 2021 - Genentech today announced the U.S. FDA Oncologic Drugs Advisory Committee voted 10 to 1 in favour of maintaining accelerated approval of Tecentriq (atezolizumab) for the treatment of adults with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy and whose tumours express high levels of PD-L1 (PD-L1–stained tumour infiltrating immune cells covering ≥5 percent of the tumour area) as determined by an FDA approved test or are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. 

Today’s Oncologic Drugs Advisory Committee meeting is part of an industry-wide review of accelerated approvals with confirmatory trials that have not met their primary outcome(s) and have yet to gain regular approvals. The advisory committee provides the FDA with independent opinions and recommendations from outside medical experts though the recommendations are not binding. 

The FDA has not announced when it will make its final decision for Tecentriq in this indication.

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