FDA Accepts sBLA and Grants Priority Review for Atezolizumab in Locally Advanced or Metastatic Urothelial Carcinoma


On January 9, the U.S. Food and Drug Administration (FDA) accepted the supplemental Biologics License Application (sBLA) and granted Priority Review for atezolizumab (Tecentriq) in the treatment of patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin chemotherapy and are either previously untreated or have had disease progression at least 12 months after receiving chemotherapy before or after surgery. Urothelial carcinoma accounts for 90% of all bladder cancers and can also be found in the renal pelvis, ureter, and urethra.

“In May 2016, atezolizumab became the first treatment approved by the FDA for people with previously treated advanced bladder cancer in more than 30 years,” said Sandra Horning, MD, Chief Medical Officer and Head of Global Product Development at Genentech, the drug’s manufacturer. “We are committed to continue working with the FDA to make atezolizumab available to more people with this type of advanced bladder cancer, specifically those who are unable to tolerate cisplatin-based chemotherapy as an initial treatment.”

This sBLA submission for atezolizumab is based on results from the phase II IMvigor210 (Cohort 1, Cohort 2) study, and the FDA will make a decision on approval by April 30, 2017.

Atezolizumab is currently approved by the FDA to treat people with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-based chemotherapy or whose disease has worsened within 12 months of neoadjuvant or adjuvant platinum-based chemotherapy. Atezolizumab is approved under accelerated approval for this indication based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. 

Atezolizumab is also approved for the treatment of people with metastatic non–small cell lung cancer who have disease progression during or following platinum-containing chemotherapy or have had disease progression on an appropriate FDA-approved targeted therapy if their tumor has EGFR or ALK gene abnormalities.

About IMvigor210

IMvigor210 is an open-label, multicenter, single-arm phase II study that evaluated the safety and efficacy of atezolizumab in people with locally advanced or metastatic urothelial carcinoma, regardless of programmed cell death ligand 1 (PD-L1) expression. People in the study were enrolled into one of two cohorts.

Cohort 1, upon which this sBLA submission is based, consisted of people who were ineligible for first-line cisplatin-based chemotherapy, and who had received no prior chemotherapies for locally advanced or metastatic urothelial carcinoma (ie, first-line) or had disease progression at least 12 months after neoadjuvant or adjuvant chemotherapy.

Cohort 2, which served as the basis for the FDA’s accelerated approval of atezolizumab in May 2016, included people whose disease had progressed during or following previous treatment with a platinum-based chemotherapy regimen or who had disease progression within 12 months of treatment with a platinum-based neoadjuvant or adjuvant chemotherapy regimen. The primary endpoint of the study was objective response rate. Secondary endpoints included duration of response, overall survival, progression-free survival, and safety.

About Atezolizumab

Atezolizumab is a monoclonal antibody designed to bind with PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both programmed cell death protein 1 (PD-1) and B7.1 receptors. By inhibiting PD-L1, atezolizumab may enable the activation of T cells. Atezolizumab may also affect normal cells.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.