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FDA grants priority review to atezolizumab for PD-L1–positive NSCLC
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The FDA granted priority review to atezolizumab for the treatment of patients with locally advanced or metastatic non–small cell lung cancer that progressed on or after platinum-containing chemotherapy.
Atezolizumab (MPDL3280A, Genentech) is intended for patients whose tumor expresses PD-L1, as determined by an FDA–approved test.
Sandra Horning
“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,” Sandra Horning, MD, chief medical officer and head of global product development at Genentech, said in a press release. “The goal of PD-L1 as a biomarker is to identify people most likely to benefit from atezolizumab alone.”
The FDA granted atezolizumab breakthrough therapy designation in February 2015 for PD-L1–positive NSCLC that progressed during or after standard treatments, such as platinum-based chemotherapy and appropriate targeted therapy for EGFR- or ALK-positive disease.
Atezolizumab also received priority review for the treatment of patients with locally advanced or metastatic urothelial carcinoma whose disease progressed during or following platinum-based chemotherapy in the metastatic setting, or whose disease worsened within 12 months of receiving platinum-based neoadjuvant or adjuvant chemotherapy.
The FDA will make a decision on approval of atezolizumab for the NSCLC indication by Oct. 19. A premarket application also is under review for a companion immunohistochemistry test (Roche Tissue Diagnostics).