European Commission approved AZ’s treatment for locally advanced, unresectable NSCLC
AstraZeneca’s durvalumab has been approved in Europe for the treatment of locally-advanced, unresectable non-small cell lung cancer (NSCLC).
The decision enables 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).
The decision was made by the EC as a result of 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 durvalumab. Approximately 89% 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. Durvalumab 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.
Durvalumab 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.