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Home Industry News AstraZeneca’s Imfinzi accepted for European regulatory review

AstraZeneca’s Imfinzi accepted for European regulatory review

10th October 2017

AstraZeneca has announced that its lung cancer therapy Imfinzi has been accepted for European regulatory review.

The European Medicines Agency has accepted the company's marketing authorisation application for Imfinzi for the treatment of patients with locally-advanced, unresectable non-small cell lung cancer (NSCLC) whose disease has not progressed following platinum-based chemoradiation therapy.

This is the first registrational submission for Imfinzi in the EU, and is supported by positive progression-free survival data for the drug demonstrated in the phase III PACIFIC trial.

An AstraZeneca statement said this marks "an important milestone for Imfinzi in a disease state where patients need better treatment options and outcomes".

Imfinzi has already received accelerated approval in the US for the treatment of patients with locally advanced or metastatic urothelial carcinoma. AstraZeneca is still assessing the therapy in the PACIFIC trial to determine its overall survival benefits.

Currently, the standard of care for patients with this form of lung disease is active monitoring following concurrent chemoradiation, but it is hoped that Imfinzi can offer advantages over this approach.

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