Posted by Michael Wonder on 10 May 2018
First and only immuno-oncology treatment, Imfinzi (durvalumab), for stage III, unresectable non-small-cell lung cancer now approved in Canada
9 May 2018 - Patients receiving Imfinzi in the PACIFIC clinical trial lived for nearly one year without their disease progressing versus placebo
AstraZeneca Canada today announced that Health Canada has approved Imfinzi (durvalumab) 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 (CRT). With this approval, Imfinzi becomes the first and only approved immuno-oncology therapy following CRT for patients in this setting. Reviewed under Health Canada’s accelerated approval framework, Imfinzi has been granted Notice of Compliance with Conditions based on data from the phase III PACIFIC trial demonstrating that Imfinzi extended progression-free survival for patients by nearly one year (11.2 months) versus placebo.
The approval of Imfinzi is based on positive progression-free survival (PFS) data from the Phase III PACIFIC trial in which Imfinzi demonstrated an improvement in median PFS of nearly one year (11.2 months) compared to placebo, representing a 48% reduction in relative risk of progression or death vs. placebo in all patients, regardless of programmed death-ligand 1 status.
