Health Canada Approves Imfinzi® (Durvalumab) as the First and Only Immunotherapy for Adult Patients with Limited-Stage Small Cell Lung Cancer (LS-SCLC) .

 

April 10 , 2025 .

MISSISSAUGA, Canada – Health Canada has granted a Notice of Compliance (NOC) for IMFINZI® (durvalumab), as monotherapy, for the treatment of adult patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following platinum-based chemoradiation therapy (CRT), following a priority review of the submission .

The approval of Imfinzi was granted based on results from the pivotal ADRIATIC Phase III trial which demonstrated statistically significant and clinically meaningful results for its dual primary endpoints of overall survival (OS) and progression-free survival (PFS) for Imfinzi compared with placebo .

The results of the ADRIATIC trial were presented during the Plenary Session of the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and subsequently published in the New England Journal of Medicine . ...