Accelerated Approval Granted to AstraZeneca’s Imfinzi

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.