Astrazeneca wins fast-track approval for bladder cancer drug

AstraZeneca has won fast-track US regulatory approval for a particular application of its most promising cancer drugs.

Durvalumab, a highly innovative immuno-oncology treatment that helps empower the patient's immune system and attack the cancer, has been given Breakthrough Therapy designation (BTD) by the US Food and Drug Administration (FDA) for inoperable or metastatic urothelial bladder cancer.

Across all applications, current consensus forecasts point to durvalumab generating revenues of over $1.5bn by 2020.

By being given the BTD, which is given to treatments for serious conditions that have shown encouraging early clinical results, the FDA will take a more “all hands-on-deck” approach and give AstraZeneca ongoing guidance and feedback throughout the clinical development process, which should speed the drug's regulatory process.

"Metastatic bladder cancer is an area of enormous unmet medical need," said Robert Iannone, the company's global head of immuno-oncology. "We are encouraged by this Breakthrough Therapy designation. We look forward to working closely with the FDA to bring durvalumab to bladder cancer patients as soon as possible."

This represents the third BTD AstraZeneca has received from the FDA for its cancer medicines.