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. [1]

Durvalumab was approved earlier in the month by the Japanese Ministry of Health, Labour and Welfare as maintenance therapy in the same patient population[2]; 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.[3]

Durvalumab, developed by AstraZeneca via Medimmune is also approved in the US[4] and Canada[5] for use in patients with bladder cancer.

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.[1]

“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”. [1]

For further information related to the first approval of durvalumab please visit Drugs[6], or to learn more about its overall development across all indications visit AdisInsight.[7]

Image credit: Carlos Alberto Gomes-Iniguez – Unsplash


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