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US FDA grants priority review to AstraZeneca's bladder cancer drug

The U.S. FDA has agreed to review AstraZeneca PLC bladder cancer candidate durvalumab, developed with the company's biologics R&D arm MedImmune.

The regulator granted the human monoclonal antibody a priority review status. A decision on the approval is scheduled for the second quarter of 2017.

Durvalumab's biologics license application submission is for patients with locally advanced or metastatic urothelial cancer showing disease progression during or after one standard platinum-based chemotherapy regimen. The application is based on the results of a phase 1/2 study of the drug in patients with advanced solid tumors.

Early data from the trial earned durvalumab a breakthrough therapy designation from the FDA in February. The drug is the subject of more than 30 other clinical trials, including tests as a monotherapy and in combination with tremelimumab in a phase 3 study as a first-line treatment of metastatic urothelial cancer, regardless of eligibility for cisplatin-based chemotherapy.

The combination of durvalumab and tremelimumab, another investigational AstraZeneca cancer candidate, is also being studied in phase 3 trials for nonsmall 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.

Leerink Partners analyst Seamus Fernandez projects sales of the two drugs to total $480 million in 2018, rising to about $3.98 billion in 2021, according to a Dec. 9 research note.