Regulatory updates on Imfinzi and Tagrisso in Europe and USA

Shares in AstraZeneca (LSE: AZN) edged higher in early dealing today, on the news that US regulators have granted its Tagrisso (osimertinib) Breakthrough Therapy designation and its European peer has accepted the marketing application for its Imfinzi (durvalumab).

The Anglo-Swedish pharma major, along with its biologics R&D arm MedImmune, revealed  that the European Medicines Agency has accepted a Marketing Authorization Application (MAA) for Imfinzi for the treatment of patients with locally-advanced (Stage III), 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 European Union.

The MAA submission acceptance is an important milestone for Imfinzi in a disease state where patients need better treatment options and outcomes. Currently, the standard of care for patients with this earlier stage of lung disease is active monitoring following concurrent chemoradiation.