Therapy Areas: Oncology
AstraZeneca announces grant by US FDA of Orphan Drug Designation to Imfinzi
15 July 2019 -

AstraZeneca Plc (LON:AZN), a global, science-led biopharmaceutical company, announced on Friday the grant by the US Food and Drug Administration (FDA) of Orphan Drug Designation (ODD) to Imfinzi (durvalumab) for the treatment of small cell lung cancer (SCLC).

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.

According to the company, this ODD 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.

Reportedly, 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.

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.

AstraZeneca is focussed on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in the three therapy areas of Oncology, Cardiovascular, Renal & Metabolism and Respiratory.