CHMP recommends Imfinzi for the treatment of locally-advanced, unresectable NSCLC. Astra Zeneca.

AstraZeneca and MedImmune, its global biologics research and development arm, aannounced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion, recommending a marketing authorisation of Imfinzi (durvalumab) for the treatment of locally-advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 on ?1% of tumour cells and whose disease has not progressed following platinum-based chemotherapy and radiation therapy (CRT).

The recommendation is based on the progression-free survival (PFS) and overall survival (OS) primary endpoints of the Phase III PACIFIC trial, and post-hoc subgroup analyses by PD-L1 expression requested by the CHMP. In the PACIFIC trial, Imfinzi demonstrated a statistically-significant and clinically-meaningful improvement in PFS and OS in “all-comer” patients. The recommended label reflects most of the patients in the trial with a known PD-L1 status.