San Francisco, CA – Genentech, a member of the Roche Group, has announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) and granted Priority Review for atezolizumab for the treatment of 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, MD, 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.”
Atezolizumab was granted Breakthrough Therapy Designation by the FDA in February 2015 for the treatment of people whose NSCLC expresses PD-L1 and whose disease progressed during or after standard treatments (such as platinum-based chemotherapy and appropriate targeted therapy for EGFR mutation-positive or ALK-positive disease). Breakthrough Therapy Designation is designed to expedite the development and review of medicines intended to treat serious or life-threatening diseases and to help ensure that people have access to them through FDA approval as soon as possible. The BLA submission for atezolizumab is based on results from clinical trials including the Phase II BIRCH study, and the FDA will make a decision on approval by October 19, 2016. A Premarket Application (PMA) is also under review by the FDA for a companion immunohistochemistry (IHC) test developed by Roche Tissue Diagnostics.
This is the second BLA acceptance and priority review for atezolizumab. On March 14, Genentech announced that the FDA had accepted the company’s BLA and granted Priority Review for atezolizumab for the treatment of people with locally advanced or metastatic urothelial carcinoma (mUC) 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 surgery (neoadjuvant) or after surgery (adjuvant). Atezolizumab is also being studied in a number of other cancers.
BIRCH is an open-label, multicenter, single-arm Phase II study that evaluated the safety and efficacy of atezolizumab in 667 people with locally advanced or metastatic NSCLC whose disease expressed PD-L1. PD-L1 expression was assessed for both tumor cells and tumor-infiltrating immune cells with an investigational IHC test based on the SP142 antibody.
According to the American Cancer Society, it is estimated that more than 224,000 Americans will be diagnosed with lung cancer in 2016 and NSCLC accounts for 85% of all lung cancers. It is estimated that approximately 60% of lung cancer diagnoses in the United States are made when the disease is in the advanced stages.
Atezolizumab is an investigational monoclonal antibody designed to bind with a protein called programmed death ligand-1 (PD-L1). Atezolizumab is designed to directly bind to PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with PD-1 and B7.1 receptors. By inhibiting PD-L1, atezolizumab may enable the activation of T cells. Atezolizumab may also affect normal cells.
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