Dr. Steinberg on the FDA Approval of Atezolizumab in Bladder Cancer

Gary D. Steinberg, MD
Published: Wednesday, May 18, 2016


Gary D. Steinberg, MD, Bruce and Beth White Family Professor, professor of Surgery, director of Urologic Oncology, University of Chicago Medicine, discusses the FDA approval of atezolizumab (Tecentriq) as a treatment for patients with 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 accelerated approval was based on data from the phase II IMvigor 210 study, in which atezolizumab demonstrated an overall response rate (ORR) of 14.8% in patients with locally advanced or mUC. This was 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.

Atezolizumab's approval is a game-changer for the treatment landscape of the disease, Steinberg explains.

 

Gary D. Steinberg, MD, Bruce and Beth White Family Professor, professor of Surgery, director of Urologic Oncology, University of Chicago Medicine, discusses the FDA approval of atezolizumab (Tecentriq) as a treatment for patients with 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 accelerated approval was based on data from the phase II IMvigor 210 study, in which atezolizumab demonstrated an overall response rate (ORR) of 14.8% in patients with locally advanced or mUC. This was 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.

Atezolizumab's approval is a game-changer for the treatment landscape of the disease, Steinberg explains.

 



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