LONDON (Alliance News) - Drugmaker AstraZeneca PLC on Friday said the US Food & Drug Administration have granted durvalumab priority review status and accepted the first biologics licence application for the drug.
The application submission, for the treatment of patients with bladder cancer whose disease has progressed during or after one standard platinumâ€‘based regimen, is based on the results of a study.
The application was granted priority status, and a Prescription Drug User Fee Act goal date for durvalumab is set for the second quarter of 2017, it added.
"The biologics licence application acceptance of durvalumab in urothelial cancer is an important milestone for patients who still face considerable unmet medical need in this area," said Chief Medical Officer Sean Bohen.
"It also represents an exciting advance for our immuno-oncology medicines as we continue to develop chemotherapy-free treatments based on the potential clinical benefits of durvalumab, both as monotherapy and in combination," Bohen added.
Shares in AstraZeneca were up 5.3% at 4,316.50 pence on Friday afternoon.
By Hannah Boland; firstname.lastname@example.org; @Hannaheboland
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