Roche’s (RHHBY.OB) Tecentriq, which was given accelerated approval, by the FDA in April 2017, for patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy, faces the FDA panel on April 28, 2021.The panel is expected to make its recommendation whether the drug’s approval should be withdrawn for this particular indication or should be converted from accelerated approval to regular approval for the same.Tecentriq was given accelerated approval by the FDA in April 2017, based on results from a phase II trial, dubbed IMvigor210, which demonstrated an objective response rate of 23.5%.However, a confirmatory phase III study, dubbed IMvigor211, the results of which were reported in May 2017, had failed to meet its primary endpoint of overall survival.Continued approval of drugs that have been granted accelerated approval depends upon verification and description of clinical benefit in confirmatory trials.RHHY.OB closed Friday’s (Mar.26, 2021) trading at $40.45, down 0.49%.