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AZN's Imfinzi Granted US Orphan Drug Designation For Small Cell Lung Cancer

AstraZeneca Plc. (AZN.L,AZN) said that the US Food and Drug Administration has granted Orphan Drug Designation to Imfinzi or durvalumab for the treatment of small cell lung cancer or SCLC.

Imfinzi is currently approved for unresectable, Stage III non-small cell lung cancer after chemotherapy and radiation therapy in more than 45 countries including the US, EU, and Japan based on the Phase III PACIFIC trial.

Imfinzi is a human monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumour's immune-evading tactics and releasing the inhibition of immune responses.

Imfinzi is also approved for previously-treated patients with advanced bladder cancer in the US, Canada, Brazil, Australia, Israel, India, United Arab Emirates, Qatar, Macau and Hong Kong.

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