12th Jul 2019 08:56
(Alliance News) - AstraZeneca PLC on Friday said it has secured Orphan Drug Designation for small cell lung cancer treatment Imfinzi from the US Food & Drug Administration.
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.
The pharmaceutical company said Imfinzi in Phase III Caspian trial showed statistically significant and clinically meaningful improvement in overall survival for patients with extensive-stage small cell lung cancer. The patients were treated with Imfinzi in combination with standard-of-care etoposide and platinum-based chemotherapy versus chemotherapy alone.
Astra also is testing Imfinzi for limited-stage small cell lung cancer treatment in the Phase III Adriatic trial. Imfinzi already is 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.
Shares in Astra were trading 1.0% lower at 6,318.12 pence each on Friday morning.
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