New clinical data support durvalumab FDA approval bid
Anglo-Swedish drugmaker AstraZeneca (LSE: AZN) has announced updated efficacy and safety data for its candidate bladder cancer therapy durvalumab.
MedImmune, the company’s biologics R&D arm, presented results from a Phase I/II study that showed an objective response rate (ORR) of 20.4% in all evaluable patients.
David Berman, head of oncology, innovative medicines, said: “The durable responses observed in this larger data set confirm the promising efficacy we’ve already seen for durvalumab in patients with advanced bladder cancer.”
“We are continuing to test durvalumab in combination with tremelimumab and as monotherapy in the bladder cancer first-line setting in our ongoing Phase III DANUBE trial.”
The company’s Biologics License Application for durvalumab in patients with locally-advanced or metastatic urothelial carcinoma was accepted for review by the US Food and Drug Administration in December last year.
The application was also granted priority review status, with a decision expected before mid-2017. Analysts forecast sales could reach $1.8 billion by 2019, including revenue from dual therapy applications with tremelimumab.
Director of the Barts Cancer Centre Thomas Powles said: “The clinical efficacy of durvalumab in patients with advanced bladder cancer is particularly encouraging. For the past three decades we’ve seen limited progress in therapy for patients, and there remains significant unmet need for new treatment options.”