FDA committee members recently voted in favor of upholding Tecentriq’s accelerated approval indication for the first-line treatment of certain adults with locally advanced or metastatic urothelial carcinoma who are ineligible for standard chemotherapy.
In a 10-to-1 vote, the Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) recently recommended in favor of keeping the accelerated approval of Tecentriq (atezolizumab) for the treatment of certain adults with locally advanced or metastatic urothelial carcinoma who are ineligible for standard chemotherapy.
The FDA did not announce when it will make a final decision on Tecentriq’s indication in this patient population.
“Today’s positive vote reaffirms that Tecentriq fills a significant unmet need for people with previously untreated metastatic bladder cancer, many of whom cannot tolerate standard of care chemotherapy and need additional options,” said Dr. Levi Garraway, chief medical officer and head of global product development at Genentech, in a news release. “Having now received positive ODAC recommendations in both bladder cancer and triple-negative breast cancer, we will continue to work with the FDA on next steps for Tecentriq in these indications.”
The vote to recommend to either uphold or discontinue this Tecentriq indication comes as part of an effort by the FDA to review the status of immunotherapies granted accelerated approval across multiple cancer indications where confirmatory trials failed to show a significant clinical benefit with treatment.
In 2017, the FDA granted Tecentriq accelerated approval for the first-line treatment of patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin-based chemotherapy. The decision was based results of the open-label, multi-center and single-arm phase 2 IMvigor210 trial, which demonstrated that Tecentriq induced an objective response rate (the percentage of patients with partial and complete responses to the treatment) of 23.5% in 119 patients who received the study drug.
The indication was extended in 2018 to include patients with a PD-L1 expression of 5% or more, based on results from the phase 3 IMvigor130 trial. Overall survival data in this trial are still being gathered and will shared with the public once available, announced Genentech.
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