Tecentriq regulatory update

FDA granted accelerated approval to an sBLA from Roche's Genentech unit for Tecentriq atezolizumab as a first-line treatment for patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin chemotherapy. Genentech said the approval is based on data from the Phase II IMvigor210 trial, in which Tecentriq led to an objective response rate (ORR) of 24% in 119 evaluable patients with locally advanced or metastatic urothelial carcinoma (see BioCentury, June 13, 2016). The humanized mAb against PD-L1 already had accelerated approval from FDA to treat urothelial carcinoma that has progressed on or after platinum-based chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. It also has standard approval as a second-line treatment of non-small cell lung cancer (NSCLC) following chemotherapy...