Richard Pazdur, MD
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 OncLive.com