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Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) 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 =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. Today's ODAC meeting is part of an industry-wide review of accelerated approvals with confirmatory trials that have not met their primary endpoint(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.