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AstraZeneca's Imfinzi gets orphan drug designation from FDA

Published on 12/07/19 at 10:07am

AstraZeneca’s cancer immunotherapy Imfinzi has been granted orphan drug status as a treatment for small cell lung cancer (SCLC).

The FDA has granted Imfinzi (Durvalumab) an Orphan Drug Designation (ODD) as a treatment for SCLC which accounts for around 15% of all lung cancer diagnoses.

SCLC is the most aggressive form of lung cancer with only 6% of patients living for more than 5 years. The FDA grants ODDs to drugs which treat diseases which affect fewer than 200,000 people in the United States.

José Baselga, Executive Vice President, R&D Oncology said: “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. We are eager to expand treatment options for patients facing such a devastating diagnosis and look forward to working with regulatory authorities to bring forward new options as soon as possible.”

Imfinzi is currently approved for non-small cell lung cancer (NSCLC) in more than 45 countries including the United States, Japan and countries in the European Union.  

Louis Goss  

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