Roche announced Monday that the FDA accepted a filing seeking approval of atezolizumab for the treatment of certain people with locally advanced or metastatic non-small-cell lung cancer (NSCLC), granting the application priority review. The agency is scheduled to make a decision on approval by October 19.
Specifically, the submission seeks clearance in patients whose disease expresses the protein PD-L1, as determined by an FDA-approved test, and who have progressed on or after platinum-containing chemotherapy. Atezolizumab, which has also been granted FDA breakthrough therapy status in this indication, is an investigational monoclonal antibody designed to bind with the PD-L1 protein.
According to Roche, the filing for atezolizumab is based on results from studies including the Phase II BIRCH trial, which evaluated the drug in 667 people with locally advanced or metastatic NSCLC whose disease expressed PD-L1. Results announced last year demonstrated that atezolizumab met the primary endpoint of the study, shrinking tumours in up to 27 percent of patients whose disease had progressed on previous treatment and also expressed the highest levels of PD-L1. At the time, the company noted that median survival had not yet been reached.
In March, the FDA granted priority review to Roche's filing seeking approval of atezolizumab to treat people with locally advanced or metastatic urothelial carcinoma 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.
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