- The FDA on Thursday designated AstraZeneca's top bladder cancer candidate durvalumab as a breakthrough therapy, accelerating the development and review process for the drug. Co-developed by AstraZeneca's biologics arm MedIummune, durvalumab has shown clinical promise in treating advanced bladder cancer after first-line treatments have failed.
- AstraZeneca also plans to develop durvalumab for treatment of lung, gastric, pancreatic, liver, and blood cancers, according to Reuters.
- Durvalumab is an anti-PD-L1 monoclonal antibody designed to boost the body's immune system to recognize and attack cancerous tumors.
AstraZeneca may be a latecomer to the cancer immunotherapy space . Both Merck's Keytruda and Bristol-Myers Squibb's Opdivo are already approved as anti-PD-1 treatments, although for lung and skin cancers. (Note that durvalumab is an anti-PD-L1 monoclonal antibody). However, as AstraZeneca plans to expand durvalumab's development to other cancers, its competitors' head start may hurt AZ in the long run.
Durvalumab has already seen some setbacks. In December 2015, AstraZeneca announced its trial evaluating the drug for treatment of non-small cell lung cancer would be insufficient to support submission as a monotherapy.
Thursday's designation by the FDA was granted based on data from a phase 1 trial evaluating durvalumab as a second-line therapy in patients with advanced urothelial bladder cancer.
Given the profound unmet medical need associated with urothelial bladder cancer—five-year survival rates are roughly 15%—durvalumab offers potential hope for patients who have few, if any, other treatment options.