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# Accelerated Approval Granted to AstraZeneca’s Imfinzi
- URL: https://www.fdaweb.com/accelerated-approval-granted-to-astrazenecas-imfinzi/
- Published: 2017-05-01T12:00:00.000Z
- Updated: 2026-09-14T22:20:55.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138581

FDA has granted accelerated approval to AstraZeneca for Imfinzi (durvalumab) for treating patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. The agency also approved Ventana Medical’s Ventana PD-L1 (SP263) Assay as a complementary diagnostic for assessing the PD-L1 protein in formalin-fixed, paraffin-embedded urothelial carcinoma tissue.

  
Approval was based on one single-arm trial involving 182 patients with locally advanced or metastatic urothelial carcinoma whose disease progressed after prior chemotherapy. In the 182 patients, the confirmed objective response rate was 26.3% in 95 patients with a high PD-L1 score and 4.1% in 73 patients with a low score. Full prescribing information is available at: [https://www.accessdata.fda.gov/drugsatfda\_docs/label/2017/761069s000lbl.pdf](https://www.accessdata.fda.gov/drugsatfda%5Fdocs/label/2017/761069s000lbl.pdf?ref=fdaweb.com).