The U.S. Food and Drug Administration (FDA) has granted Priority Review to Genentech’s supplemental Biologics License Application (sBLA) for atezolizumab (Tecentriq) as treatment of patients with locally advanced or metastatic urothelial carcinoma who are ineligible to receive cisplatin chemotherapy, and are either treatment-naive or have disease progression at least 12 months after receiving neoadjuvant or adjuvant chemotherapy.1
This sBLA submission is based on findings from cohort 1 of the multicenter, open-label, phase 2 IMvigor210 trial (ClinicalTrials.gov Identifier: NCT02951767), which evaluated the safety and efficacy of atezolizumab among patients with locally advanced or metastatic urothelial carcinoma regardless of PD-L1 expression.
Treatment-naive patients and those ineligible to receive cisplatin-containing chemotherapy received atezolizumab on day 1 of each 21-day cycle until disease progression or unacceptable toxicity.
Preliminary results presented at the 2016 American Society of Clinical Oncology (ASCO) annual meeting in Chicago, Illinois, showed that 24% (95% CI, 16-32) of the 28 evaluable patients achieved an objective response, including 8% who achieved a complete response. Median overall survival was 14.8 months (95% CI, 10.1-not estimable) and the 12-month landmark overall survival rate was 57%.
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The FDA is expected to make a decision on approval by April 30, 2017.
Atezolizumab, a PD-L1 blocking antibody, is approved by the FDA for the treatment of patients with locally advanced or metastatic urothelial carcinoma who experience disease progression during or after platinum-based chemotherapy or whose disease has worsened within 12 months of neoadjuvant or adjuvant platinum-based chemotherapy.
- FDA grants Genentech’s cancer immunotherapy Tecentriq (atezolizumab) Priority Review in additional type of advanced bladder cancer. Genentech website. https://www.gene.com/media/press-releases/14652/2017-01-08/fda-grants-genentechs-cancer-immunothera. Published January 8, 2017. Accessed January 10, 2017.