FDA Grants Atezolizumab Priority Review for Advanced Bladder Cancer
Atezolizumab being examined as first-line treatment for individuals ineligible for cisplatin chemotherapy.
The FDA has accepted Genentech’s supplemental Biologics License Application (sBLA), and granted Priority Review for atezolizumab (Tecentriq) for the treatment of locally advanced or metastatic urothelial carcinoma (mUC).
According to a company press release, approval is sought for atezolizumab to treat patients with mUC who are ineligible for cisplatin chemotherapy, and are either previously untreated (first-line) or have disease progression at least 12 months after receiving chemotherapy before surgery or after surgery.
The sBLA submission for atezolizumab is based on results from the open-label, multicenter, single-arm phase 2 IMvigor2010 study, which evaluated the safety and efficacy of atezolizumab in people with locally advanced or mUC, regardless of PD-L1 expression, according to the release.
For the study, the investigators enrolled participants into 1 of 2 cohorts. Cohort 1 consisted of individuals who were ineligible for first-line cisplatin-based chemotherapy, and who had received no prior chemotherapies for locally advanced or mUC, or had disease progression at least 12 months after neoadjuvant or adjuvant chemotherapy. The release noted that the sBLA submission was based upon cohort 1.
Cohort 2 served as the basis for the FDA’s accelerated approval of atezolizumab in May 2016, and included participants whose disease had progressed during or following prior treatment with platinum-based chemotherapy, or who had disease progression within 12 months of treatment with platinum-based neoadjuvant or adjuvant chemotherapy regimen.
The primary endpoint of the study was objective response rate, according to the release. Secondary endpoints included duration of response, overall survival, progression-free survival, and safety.
“In May 2016, Tecentriq 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. “We are committed to continue working with the FDA to make Tecentriq 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.”
The FDA is expected to make its decision on approval by April 30, 2017.