BRIEF—New approval for AstraZeneca's Imfinzi in Europe

AstraZeneca’s Imfinzi (durvalumab) has been approved in the European Union for the 1st-line treatment of adults with extensive-stage small cell lung cancer (ES-SCLC) in combination with a choice of chemotherapies, etoposide plus either carboplatin or cisplatin.

The approval by the European Commission was based on positive results from the Phase III CASPIAN trial showing Imfinzi plus chemotherapy demonstrated a statistically-significant and clinically-meaningful overall survival (OS) benefit for the 1st-line treatment of patients with ES-SCLC.

It follows the recommendation for approval by the Committee for Medicinal Products for Human Use of the European Medicines Agency in July 2020.

This is the first immunotherapy regimen to offer both a sustained survival benefit and an improved response rate, as well as a choice of chemotherapies and convenient dosing every four weeks during maintenance.

Imfinzi, which generated second-quarter 2020 sales of $492 million (up 46% year-on-year), is approved in the curative-intent setting of unresectable, Stage III NSCLC after chemoradiation therapy in the US, Japan, China, across the EU and in many other countries, based on results from Phase III PACIFIC trial.