ODAC Decision Means Atezolizumab Will Maintain It’s Indication for Frontline Urothelial Carcinoma


Accelerated approval for atezolizumab in the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for certain chemotherapy regimens was maintained by an FDA committee vote.

A meeting of the FDA’s Oncologic Drugs Advisory Committee (ODAC) ended in a 10-to-1 vote in favor of upholding the accelerated approval of atezolizumab (Tecentriq) for the treatment of certain adult patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for standard chemotherapy regimens.1

Patients who cannot received cisplatin-based chemotherapy and who express PD-L1 in at least 5% of cells by an FDA approved test and those who are not eligible for any platinum-based chemotherapy, regardless of PD-L1 expression, will still be eligible to receive the PD-L1 inhibitor. This indication was originally granted accelerated approval back in 2017 based on objective response rate and duration data from a phase 2 trial.2

“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,” Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development at Genentech, a member of the Roche Group, said in a press 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 IMvigor210 trial (NCT02108652) was an open-label, multicenter, single-arm study that evaluated safety and efficacy of atezolizumab in patients with locally advanced or mUC, regardless of PD-L1 expression. In cohort 1, which served as rationale for the accelerated approval, all patients regardless of PD-L1 expression (n = 119) had an objective response rate of 23.5% (95% CI, 16.2%-32.2%), with 6.7% of patients experiencing a complete response to therapy. In patients with PD-L1 expression of 5% or more, those rates were 28.1% (95% CI, 13.8%-46.8%) and 6.3%, respectively.

In 2018, the FDA updated this indication to include patients with high PD-L1 expression based on findings from the phase 3 IMvigor130 trial (NCT02807636), a postmarketing requirement for the frontline use indication.1,3 The randomized trial showed statistically significant improvement in progression-free survival, 1 of 2 co-primary end points, with atezolizumab plus platinum versus placebo/platinum in patients with first-line mUC (HR, 0.82; 95% CI, 0.70-0.96; P = .007).4 The trial continues for its second primary end point of overall survival.4

This work to reevaluate the indication for atezolizumab is part of an industry-wide effort by the FDA to review the status of immunotherapy agents granted accelerated approval across 6 tumor indications whose confirmatory trials did not indicate a clinical benefit to treatment.

On the first day of the meeting, the committee voted 7 to 2 in favor of maintaining the accelerated approval granted to atezolizumab plus nab-paclitaxel (Abraxane) to treat adult patients with unresectable, locally advanced or metastatic triple-negative breast cancer whose tumors express PD-L1, as determined by an agency-approved test.


1. FDA Advisory Committee Votes in Favor of Maintaining Accelerated Approval of Genentech’s Tecentriq for Previously Untreated Metastatic Bladder Cancer. News release. Genentech, a member of the Roche Group. April 28, 2021. Accessed April 29, 2021. https://bit.ly/3eENQcn

2. FDA grants Roche’s TECENTRIQ® (atezolizumab) accelerated approval as initial treatment for certain people with advanced bladder cancer. News release. Roche. April 18, 2017. Accessed April 29, 2021. https://bit.ly/3t5fS5T

3. FDA updates prescribing information for Keytruda and Tecentriq. FDA. August 16, 2018. Accessed April 29, 2021. https://bit.ly/3xAsmpG

4. Galsky MD, Arija JÁA, Bamias A, et al; IMvigor130 Study Group. Atezolizumab with or without chemotherapy in metastatic urothelial cancer (IMvigor130): a multicentre, randomised, placebo-controlled phase 3 trial. Lancet. 2020;395(10236):1547-1557. doi: 10.1016/S0140-6736(20)30230-0

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