The U.S. FDA granted breakthrough therapy designation for AstraZeneca’s durvalumab as a treatment for bladder cancer, the company announced on Wednesday.
The experimental drug, a PD-L1 therapy, is for the treatment of patients with programmed death ligand-1 positive inoperable or metastatic urothelial bladder cancer, in which the tumor has progressed during or after one standard platinum-based regimen.
Durvalumab is an investigational monoclonal antibody directed against PD-L1. The breakthrough therapy designation is meant to expedite the development of new drugs based upon encouraging clinical results.
The drug, durvalumab, is also being developed as a treatment for lung, head and neck, gastric, pancreatic, liver and blood cancers.
In October 2015, AstraZeneca temporarily halted two clinical trials for an experimental drug combination of a compound called AZD9261 with immune system-boosting durvalumab to treat advanced non-small cell lung cancer. Although no deaths were reported, there was an increase in reports of lung disease.
Durvalumab, which faces competition from rival products manufactured by Bristol-Myers Squibb, Merck and Roche, could provide AstraZeneca with $6.5 billion in annual sales, reported Reuters.
Filed Under: Drug Discovery
