The Food and Drug Administration has granted priority review for atezolizumab for the treatment of people with locally advanced or metastatic non–small-cell lung cancer expressing the programmed death ligand–1 protein (PD-L1) who 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 Dr. Sandra Horning, chief medical officer and head of global product development for Roche and Genentech, in a press release. “The goal of PD-L1 as a biomarker is to identify people most likely to benefit form atezolizumab alone.”
In February 2015, the FDA also granted the drug breakthrough therapy designation for the treatment of people with non–small-cell lung cancer expressing PD-L1 that progressed during or after standard treatments.
Earlier this year, the FDA granted a priority review of atezolizumab for the treatment of people with locally advanced or metastatic urothelial carcinoma, who had disease progression during or following platinum-based chemotherapy in the metastatic stetting or disease worsening within 12 months of receiving platinum-based chemotherapy before or after surgery.