The US Food and Drug Administration (FDA) has granted priority review for Roche’s Tecentriq (atezolizumab) in combination with chemotherapy for treating extensive-stage small cell lung cancer (ES – SCLC).
The supplemental Biologics License Application (sBLA) submitted by the company for Tecentriq is based on results from its Phase III IMpower133 study.
According to Roche, the multi-centre, double-blinded, randomised placebo-controlled study met its co-primary endpoints of overall survival (OS) and progression-free survival (PFS) in the initial treatment of people with ES-SCLC.
The FDA is expected to make its final decision on approval by 18 March next year.
Roche Global Product Development head and chief medical officer Sandra Horning said: “It’s been more than 20 years since there has been a new initial treatment option for extensive-stage small cell lung cancer that delivers a clinically meaningful survival benefit.
“We are working closely with the FDA to bring this Tecentriq-based regimen to people with this difficult-to-treat type of lung cancer as soon as possible.”
Currently, Tecentriq is approved in the US to treat patients with metastatic non-small cell lung cancer (NSCLC) showing disease progression during or following platinum-containing chemotherapy.
It can also be used to treat patients who have progressed on an appropriate FDA-approved targeted therapy if their tumour has ALK or EGFR gene abnormalities.
A monoclonal antibody, Tecentriq is developed to bind with a protein called PD-L1 expressed on tumour cells and tumour-infiltrating immune cells preventing interactions with PD-1 and B7.1 receptors.
According to the company, Tecentriq can be used as a foundational combination partner with cancer immunotherapies, targeted medicines and various chemotherapies to treat various forms of cancers.