In July 2018 durvalumab (Imfinzi ®) received a positive opinion from the Committee for Medical Products for Human Use (CHMP). The committee recommended marketing authorisation for the agent in Europe 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. 
Durvalumab was approved earlier in the month by the Japanese Ministry of Health, Labour and Welfare as maintenance therapy in the same patient population; and in February 2018 the US FDA approved durvalumab for the treatment of unresectable, stage III NSCLC, whose cancer had not progressed after chemoradiation therapy.
The recommendation is based on the positive primary endpoint data of the Phase III PACIFIC trial, in addition to post-hoc subgroup analyses by PD-L1 expression that was requested by the CHMP.
“There have been no new treatments in this setting for decades. With approximately a third of European non-small cell lung cancer patients presenting with this stage of disease, we are excited by this potential new standard of care in this curative-intent setting,” said Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca. “The CHMP positive opinion brings European patients closer to having a treatment following chemoradiation therapy”. 
Image credit: Carlos Alberto Gomes-Iniguez – Unsplash