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FDA grants priority review to Tecentriq for bladder cancer
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The FDA granted priority review to atezolizumab for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin chemotherapy, and who are previously untreated or had disease progression at least 12 months after receiving chemotherapy before or after surgery, according to the drug’s manufacturer.
The supplemental biologics license application is based on results from the open-label, multicenter, single-arm phase 2 IMvigor210 study — designed to evaluate the safety and efficacy of atezolizumab (Tecentriq, Genentech) in patients with locally advanced or metastatic urothelial carcinoma, regardless of PD-L1 expression.
ORR served as the primary endpoint. Secondary endpoints included duration of response, OS, PFS and safety.
The FDA will make its decision on approval by April 30, according to a press release.
Atezolizumab is approved to treat:
patients 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; and
patients with metastatic non–small cell lung cancer who have disease progression during or following platinum-containing chemotherapy, and have progressed on an appropriate FDA–approved targeted therapy if their tumor has EGFR or ALK gene abnormalities.
“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,” Sandra Horning, MD, chief medical officer and head of global product development at Genentech, said in a press release. “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.”