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# FDA Accepts AstraZeneca BLA for Bladder Cancer Therapy
- URL: https://www.fdaweb.com/fda-accepts-astrazeneca-bla-for-bladder-cancer-therapy/
- Published: 2016-12-09T12:00:00.000Z
- Updated: 2026-09-14T21:53:27.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137535

FDA has accepted for priority review an AstraZeneca BLA for durvalumab, a PD-L1 human monoclonal antibody for treating patients with locally advanced or metastatic urothelial carcinoma (UC) whose disease has progressed during or after one standard platinum-based regimen. The agency has set a user fee review target for the second quarter of 2017.

Durvalumab is also being tested as monotherapy and in combination with tremelimumab (CTLA-4 mAb) in the Phase 3 DANUBE trial as first-line treatment for patients with metastatic UC, regardless of eligibility for cisplatin-based chemotherapy, AstraZeneca says. The combination is also being studied in Phase 3 trials in non-small cell lung cancer, head and neck squamous cell carcinoma and in Phase 2 and earlier trials in gastric cancer, pancreatic cancer, hepatocellular carcinoma and blood cancers, it adds.