Supplemental application to FDA for Tecentriq (atezolizumab) for locally advanced urothelial carcinoma patients ineligible for cisplatin chemotherapy.- Genentech/Roche

Genentech, announced that the FDA has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for Tecentriq (atezolizumab) for the treatment of people with locally advanced or metastatic urothelial carcinoma (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 (neoadjuvant) or after surgery (adjuvant). Urothelial carcinoma accounts for 90 percent of all bladder cancers and can also be found in the renal pelvis, ureter and urethra.This sBLA submission for Tecentriq is based on results from the Phase II IMvigor210 study, and the FDA will make a decision on approval by April 30, 2017

Comment: 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. This new application is intended 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.