Genentech announced that the Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) and granted Priority Review for Tecentriq (atezolizumab). The sBLA proposes the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are ineligible for cisplatin chemotherapy, and are either previously untreated or have disease progression at least 12 months after receiving chemotherapy before (neoadjuvant), or after surgery (adjuvant).
Tecentriq is currently approved to treat patients with locally advanced or metastatic UC 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. Last October, it was also approved to treat patients with metastatic non-small cell lung cancer (NSCLC) with disease progression during or following platinum-containing chemotherapy and have progressed on an FDA-approved targeted therapy if their tumor has EGFR or ALK gene abnormalities.
The new sBLA submission was based on results from a Phase 2, open-label, multicenter, single-arm study, IMvigor210. Data from this study also served as the basis for the FDA’s accelerated approval of Tecentriq last May.
The FDA will make a decision on the sBLA by April 30, 2017.
For more information visit Tecentriq.com.