The US Food and Drug Administration (FDA) has granted priority review status to biologics license application (BLA) submitted by Roche for its cancer immunotherapy atezolizumab, as a treatment in locally advanced or metastatic non-small cell lung cancer (NSCLC).
Atezolizumab is an investigational monoclonal antibody that is designed to bind with a protein called programmed death ligand-1 (PD-L1).
By inhibiting PD-L1 expressed on tumour cells and tumour-infiltrating immune cells, atezolizumab may enable the activation of T cells and also affect normal cells.
The antibody has also received a breakthrough therapy designation by the FDA in February last year for the treatment of people whose NSCLC expresses PD-L1 and whose disease progressed during or after standard treatments.
The BLA is based on results from clinical trials including the Phase II BIRCH study, in which safety and efficacy of atezolizumab was evaluated in people with locally advanced or metastatic NSCLC whose disease expressed PD-L1.
Roche global product development head and chief medical officer Dr Sandra Horning said: "In a study of atezolizumab in people with previously treated advanced lung cancer, PD-L1 expression correlated with how well they responded to the medicine.
"The goal of PD-L1 as a biomarker is to identify people most likely to benefit from atezolizumab alone."
In March this year, FDA also accepted the company’s BLA and granted priority review status for atezolizumab for the treatment of people with locally advanced or metastatic urothelial carcinoma (mUC).