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MedImmune Receives “Breakthrough” Status from FDA for Cancer Drug

Thursday, February 25, 2016  
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A cancer immunotherapy drug under development at MedImmune, received "breakthrough" status from the Food and Drug Administration for its use in patients with metastatic bladder cancer.

MedImmune, the research and development arm for AstraZeneca, has multiple clinical trials in its pipeline for the drug candidate durvalumab, or MEDI4736, to treat non-small cell lung cancer, as well as head and neck, bladder, gastric, pancreatic, liver and blood cancers. The drug candidate inhibits what's known as a programmed death-ligand, or PD-L1 protein, which cancer uses to suppress the immune system.

The breakthrough therapy designation means the FDA will expedite the development and review of the drug. That includes allowing the company a rolling submission of regulatory documents and easier access to agency officials. MedImmune officials said the designation was based on early clinical data from a Phase I trial in patients with advanced metastatic bladder cancer.

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