Clinical trails for the cancer drug durvalumab is halted by regulators, announced Drugmaker AstraZeneca.
AstraZeneca said that the US Food and Drug Administration's partial hold on new patients with that kind of condition came in response to concerns over bleeding. The company said it had submitted its analysis of reported adverse events to regulators for review in order to address the issues and restart patient enrolment as soon as possible.
AstraZeneca has pinned hopes on durvalumab as a potential breakthrough treatment for several forms of cancer. The immunotherapy is designed to use the patient's own defence system to attack tumours, overwhelming their immune-evading systems, and is being studied as a potential treatment for various forms of the disease, including bladder, gastric, pancreatic, head and neck, and blood cancers.
The increased focus on R&D comes as it attempts to re calibrate following the recent losses of patent protection for mass-market blockbusters such as cholesterol treatment Crestor and its Nexium heartburn pill. AstraZeneca has described durvalumab as the cornerstone of its bid to develop drugs that can harness the body's immune system to fight cancer.