US FDA accepts first biologics license application for Astra’s durvalumab

The US Food and Drug Administration has accepted the first biologics licence for AstraZeneca’s durvalumab in bladder cancer and given the drug priority review status.

The submission, for the treatment of patients with locally advanced or metastic urothelial carcinoma whose disease has progressed during or after one standard platinum‑based regimen, is based on the results of a study.

AstraZeneca said durvalumab has been granted priority review status with a Prescription Drug User Fee Act set for the second quarter of 2017.

Sean Bohen, executive vice president of Global Medicines Development and chief medical officer, said: "The BLA acceptance of durvalumab in urothelial cancer is an important milestone for patients who still face considerable unmet medical need in this area.

“It also represents an exciting advance for our Immuno-Oncology medicines as we continue to develop chemotherapy-free treatments based on the potential clinical benefits of durvalumab, both as monotherapy and in combination."

At 150 GMT, AZN shares were up 3.3% to 4,251p.