EC clears AZ’ Imfinzi for locally-advanced, unresectable NSCLC

by | 25th Sep 2018 | News

AstraZeneca’s Imfinzi has been approved in Europe for the treatment of locally-advanced, unresectable non-small cell lung cancer (NSCLC).

AstraZeneca’s Imfinzi has been approved in Europe for the treatment of locally-advanced, unresectable non-small cell lung cancer (NSCLC).

The decision allows doctors to prescribe the drug for adults with stage III NSCLC whose tumours express PD-L1 on ≥1% of tumour cells and whose disease has not progressed following platinum-based chemotherapy and radiation therapy (CRT).

It follows data from the Phase III PACIFIC trial, which AZ says showed a “compelling overall survival benefit and progression-free survival of more than 11 months” in patients given Imfinzi (durvalumab).

Up to 89 percent of patients with Stage III NSCLC will progress to metastatic disease, highlighting the urgent need for new treatment options.

“Patients in Europe diagnosed with locally-advanced, unresectable non-small cell lung cancer now have a new treatment option. Imfinzi is the only immunotherapy to be approved in this curative-intent setting, and we are proud to bring a new standard of care for this difficult disease,” said Dave Fredrickson, executive vice president, head of the Oncology Business.

Imfinzi is a human monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumour’s immune-evading tactics and releasing the inhibition of immune responses.

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