AstraZeneca Plc (AZN.L,AZN) announced Tuesday that the European Union has approved Imfinzi (durvalumab) for the 1st-line treatment of extensive-stage small cell lung cancer or ES-SCLC.
Imfinzi is now approved to treat adults with ES-SCLC in combination with a choice of chemotherapies, etoposide plus either carboplatin or cisplatin.
SCLC is a highly aggressive, fast-growing form of lung cancer that typically recurs and progresses rapidly despite initial response to chemotherapy.
The EU approval for Imfinzi was based on positive results from the Phase III CASPIAN trial showing Imfinzi plus chemotherapy demonstrated a statistically significant and clinically meaningful overall survival.
It follows the recommendation for approval by the Committee for Medicinal Products for Human Use of the European Medicines Agency in July 2020.
The CASPIAN trial met the primary endpoint of OS for Imfinzi plus chemotherapy in June 2019, reducing the risk of death by 27% versus chemotherapy alone.
The CASPIAN trial used a fixed dose of Imfinzi(1500mg) administered every three weeks for four cycles while in combination with chemotherapy and then every four weeks until disease progression.
Imfinzi in combination with etoposide and either carboplatin or cisplatin is also approved in the US, Japan and several other countries for the treatment of ES-SCLC in the 1st-line setting and is currently under regulatory review in other countries.
Imfinzi is also being tested following concurrent chemoradiation therapy in patients with limited-stage SCLC in the Phase III ADRIATIC trial.
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