The U.S. Food and Drug Administration (FDA) has agreed to give Priority Review to Genentech’s application to approve Tecentriq (atezolizumab) for certain patients with locally advanced or metastatic urothelial carcinoma (mUC). The designation, which is granted to drugs that offer major advances in the treatment of a serious disease, will cut the review process from 10 months to six.
The action date for the FDA’s decision on Tecentriq is set for April 30.
“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,” Sandra Horning, MD, chief medical officer and head of Global Product Development, said in a news release. “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.”
Genentech’s supplemental Biologics Licence Application (sBLA) is based on data from the Cohort 1 of the Phase 2 IMvigor210 study (NCT02951767), an open-label, muticenter, single-arm trial designed to assess the safety and efficacy of Tecentriq in patients with locally advanced or metastatic urothelial carcinoma, independent of their PD-L1 levels.
The study was divided in two cohorts. Cohort 1 assessed patients who were ineligible for first-line, platinum-based chemotherapy and either had not undergone chemotherapy or whose disease had progressed at least 12 months after neoadjuvant (before surgery) or adjuvant (after surgery) chemotherapy. Cohort 2 assessed Tecentriq in patients whose disease progressed during or after treatment with a platinum-based chemotherapy regimen, or worsened within 12 months of treatment with a platinum-based neoadjuvant or adjuvant chemotherapy regime.
The study’s primary goal was to observe response rate. Secondary endpoints included the duration of the response, progression-free survival, overall survival, and safety.
Based on the duration and tumor response seen in Cohort 2, the FDA in May 2016 granted Tecentriq accelerated approval. Continued approval for patients, such as those in the group will require further test results to confirm the treatment’s safety and efficacy.
The sBLA is seeking approval to use Tecentriq in mUC patients who are ineligible for Platinol chemotherapy as a first-line, or in patients who received adjuvant or neoadjuvant platinum-based chemotherapy but whose disease progressed about a year after receiving the therapy.