EMA accepts marketing application for Imfinzi to treat NSCLC patients
The European Medicines Agency (EMA) has accepted a marketing authorisation application (MAA) for AstraZeneca and MedImmune’s Imfinzi (durvalumab) to treat patients with locally advanced, unresectable non-small-cell lung cancer (NSCLC).
MedImmune is the global biologics research and development division of AstraZeneca.
Locally advanced (Stage III) lung cancer is usually divided into two stages, IIIA and IIIB, both defined by the extent to which the disease has spread locally and the possibility of surgery.
Imfinzi is a human monoclonal antibody directed against PD-L1, blocks PD-L1 interaction with PD-1 and CD80 on T-cells, counters the tumour's immune-evading tactics and induces an immune response.
The current application is the first registrational submission for Imfinzi in the European Union (EU) and has been accepted by the EMA for Stage III, unresectable NSCLC patients whose disease has not progressed following platinum-based chemoradiation therapy.
The submission is based on positive progression-free survival (PFS) data obtained from the randomised, double-blinded, placebo-controlled, multi-centre Phase III PACIFIC trial, which continues to evaluate its other primary endpoint of overall survival (OS).
Involving approximately 700 patients, the trial is currently being carried out in 235 centres across 26 nations.
The primary endpoints of the trial are progression-free survival (PFS) and overall survival (OS), while secondary endpoints include landmark PFS and OS, objective response rate (ORR) and duration of response.
In addition, AstraZeneca’s Tagrisso (osimertinib) has secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for the first-line treatment of patients with metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small-cell lung cancer (NSCLC).