The Food and Drug Administration has granted accelerated approval to atezolizumab for the treatment of locally advanced or metastatic urothelial carcinoma in patients who experienced disease progression during or following platinum-based chemotherapy, along with a companion diagnostic.

Atezolizumab, marketed as Tecentriq by Genentech, is the first and only FDA-approved anti-PDL1 immunotherapy for urothelial carcinoma.

This accelerated approval is based on a 14.8% overall response rate (95% confidence interval, 11.1-19.3) reported from the open-label, multicenter, phase II IMvigor clinical trial of 310 patients, the FDA said in a written statement.

Just over one-fourth (26%) of participants who tested positive for PD-L1 expression experienced a tumor response, compared with 9.5% of participants who were negative for PD-L1 expression. The FDA, therefore, also approved the Ventana PD-L1 (SP142) assay to detect PD-L1 protein expression levels on patients’ tumor-infiltrating immune cells, which will help guide treatment decisions.

The most common adverse events reported in the single-arm trail of atezolizumab were urinary tract infection (9%), anemia (8%), fatigue (6%), and difficulty breathing (4%). Other serious side effects included pneumonitis, hepatitis, colitis, hormone gland problems, neuropathy, meningocephalitis, eye problems, severe infections, and severe infusion reactions. Three people (0.9%) experienced sepsis, pneumonitis, or intestinal obstruction that led to death, Genentech reported in a written statement.

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