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Astrazeneca Plc - Imfinzi granted US Orphan Drug Designation for small cell lung cancer

AstraZeneca today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Imfinzi (durvalumab) for the treatment of small cell lung cancer (SCLC).

SCLC constitutes about 15% of all lung cancer diagnoses. It is the most aggressive type of lung cancer with only 6% of patients alive after five years. The FDA grants ODD 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.


In June 2019, the Phase III CASPIAN trial met its primary endpoint with Imfinzi by showing a statistically-significant and clinically-meaningful improvement in overall survival for patients with extensive-stage SCLC. These patients were treated with Imfinzi in combination with standard-of-care etoposide and platinum-based chemotherapy vs. chemotherapy alone. Results will be shared at a forthcoming medical meeting. Imfinzi is also being tested following concurrent chemoradiation therapy in limited-stage SCLC in the Phase III ADRIATIC trial.


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 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.