FDA Grants Priority Review to Lung Cancer Drug


Atezolizumab was previously granted Breakthrough Therapy Designation for NSCLC in February 2015.

The FDA has granted priority review status for atezolizumab, a drug that treats locally advanced or metastatic non-small cell lung cancer (NSCLC) expressing the PD-L1 protein.

Atezolizumab was previously granted Breakthrough Therapy Designation for NSCLC in February 2015, and was previously granted priority review for a different type of cancer.

On March 14, 2016, atezolizumab was granted priority status for locally advanced or metastatic urothelial carcinoma whose disease progressed during or following platinum-based chemotherapy in the metastatic setting, or whose disease progressed within 12 months of receiving platinum-based chemotherapy before surgery or after surgery.

The NSCLC Biologics License Application submission was based on results from several clinical trials, including the open-label, multicenter, single-arm phase 2 BIRCH study.

The study enrolled 667 patients with locally advanced or metastatic NSCLC that expressed PD-L1 to test the safety and efficacy of atezolizumab. Participants were administered 1200-mg of atezolizumab intravenously, every 3 weeks.

Throughout the trial, researchers used an IHC test to assess PD-L1 expression for both tumor cells and tumor-infiltrating immune cells, based on the SP142 antibody.

“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, MD, Genentech chief medical officer and head of Global Product Development. “The goal of PD-L1 as a biomarker is to identify people most likely to benefit from atezolizumab alone.”

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