AstraZeneca PLC on Friday said Imfinzi has been approved in the US for the treatment of resectable non-small cell lung cancer before and after surgery.

The Cambridge-based pharmaceuticals firm said the approval by the US Food & Drug Administration was based on positive results from the Aegean trial, which were published in the New England Journal of Medicine in October 2023.

Results from an interim analysis of event-free survival showed a 32% reduction in the risk of recurrence, progression events or death versus chemotherapy alone in patients treated with Imfinzi before and after surgery.

Dave Fredrickson, executive vice president for the Oncology Business Unit, said: ‘Today’s approval of Imfinzi in resectable early-stage lung cancer builds on its strong foundation of changing clinical practice in unresectable Stage III disease. We remain committed to bringing novel approaches like Aegean to early lung cancer settings where cure is the goal of treatment.’

AstraZeneca said Imfinzi was generally well tolerated, and no new safety signals were observed.

Imfinzi is also approved in the UK, Switzerland and Taiwan in this setting based on the Aegean results. Regulatory applications are currently under review in the EU, China and several other countries in this indication, the firm noted.

On Thursday, AstraZeneca said Imfinzi had been granted priority review and breakthrough therapy designation for patients with limited-stage small cell lung cancer in the US.

The company’s supplemental Biologics License Application for Imfinzi was based on the results from the positive Adriatic Phase III trial in patients with limited-stage small cell lung cancer whose disease has not progressed following platinum-based concurrent chemoradiotherapy.

Shares in AstraZeneca were flat at 13,166.00 pence each in London on Friday morning. The wider FTSE 100 index was down 0.2%.

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