- AstraZeneca said the US Food and Drug Administration had granted Orphan Drug Designation to its treatment of small cell lung cancer.

The FDA grants Orphan Drug Designation status to medicines and potential new medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US.

'This Orphan Drug Designation comes on the heels of positive results from the Phase III CASPIAN trial, which is the first trial to offer the flexibility of combining immunotherapy with different platinum-based regimens in small cell lung cancer,' José Baselga, Executive Vice President, R&D Oncology.

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

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