LONDON (Alliance News) - AstraZeneca PLC said Wednesday that its drug durvalumab has been granted a breakthrough therapy designation by the US Food and Drug Administration for the treatment of PD-L1 positive urothelial bladder cancer.
This designation is given to speed up the development of new drugs that are intended to treat a serious condition, demonstrate a substantial improvement over available therapies, or where there is significant unmet medical need.
Durvalumab was granted this designation based on early clinical data from a phase I trial in patients with advanced metastatic urothelial bladder cancer whose tumour has progressed during or after one standard platinum-based regimen.
The compound is also being tested in first-line bladder cancer on its own, as well as in combination with tremelimumab.
By Hana Stewart-Smith; hanassmith@alliancenews.com; @HanaSSAllNews
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Astrazeneca (AZN)