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FDA Approves Atezolizumab in Bladder Cancer

Shirish Gadgeel, MD

Richard Pazdur, MD

The FDA granted the PD-L1 inhibitor atezolizumab (Tecentriq) an accelerated approval as a treatment for patients with locally advanced or metastatic urothelial carcinoma (mUC) whose disease progressed during or after platinum-based chemotherapy, or within 12 months of receiving platinum-containing chemotherapy, either before or after surgery.

The approval was based on data from the phase II IMvigor 210 study, in which atezolizumab had an overall response rate (ORR) of 14.8% in patients with locally advanced or mUC, regardless of PD-L1 expression. Among patients with PD-L1 expression ≥5%, ORR was 26%. The PD-L1 assay Ventana PD-L1 (SP142) was concurrently approved as a companion diagnostic.

“Tecentriq provides these patients with a new therapy targeting the PD-L1 pathway," Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, said in a statement. “Products that block PD-1/PD-L1 interactions are part of an evolving story about the relationship between the body's immune system and its interaction with cancer cells." Click here to read the full article at

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