The US Food and Drug Administration (FDA) has granted a priority review for Roche’s Tecentriq (atezolizumab) as an adjuvant treatment following surgery and platinum-based chemotherapy for people with non-small cell lung cancer (NSCLC) whose tumours express PD-L1≥1%.
The application is being reviewed by the FDA under the real-time oncology review pilot programme, which aims to explore a more efficient review process to ensure safe and effective treatments are available to patients as early as possible.
“New treatment options are urgently needed in early-stage non-small cell lung cancer to help the nearly 50% of people who currently experience a recurrence following surgery,” said Levi Garraway, chief medical officer and head of global product development at Roche.
“Tecentriq is the first cancer immunotherapy to show a clinically meaningful benefit in the adjuvant lung cancer setting, and we’re working closely with the FDA to bring this significant advancement to patients as quickly as possible,” he added.
This application is based on disease-free survival (DFS) results from an interim analysis of the Phase III IMpower010 study, the first and only Phase III study of a cancer immunotherapy to demonstrate positive results in the adjuvant lung cancer setting.
In this study, Tecentriq treatment reduced the risk of disease recurrence or death by 34% following surgery and chemotherapy in patients with Stage II-IIIA NSCLC with PD-L1 expressing tumours.
Following the priority review, the FDA is expected to make a decision on Tecentriq in this indication by 1 December 2021.