Genentech’s experimental lung cancer immunotherapy atezolizumab has been granted a priority review by the US Food and Drug Administration, with a decision now expected by October 19.
The Roche group is seeking to get approval for the drug to treat people with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease expresses the protein PD-L1 (programmed death ligand-1), as determined by an FDA-approved test, and who have progressed on or after platinum-containing chemotherapy.
“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,” said Sandra Horning, chief medical officer and head of Global Product Development at Genentech. “The goal of PD-L1 as a biomarker is to identify people most likely to benefit from atezolizumab alone.”
Atezolizumab is also currently being assessed by the FDA under a priority review as a treatment for locally advanced or metastatic urothelial carcinoma (mUC) in patients who had disease progression during or following platinum-based chemotherapy in the metastatic setting, or whose disease worsened within 12 months of receiving platinum-based chemotherapy before or after surgery.
There are currently 11 ongoing or planned Phase III studies of atezolizumab across certain kinds of lung, kidney, breast and bladder cancer.