Roche’s cancer immunotherapy for lung cancer gets US FDA priority review
pharmafile | April 11, 2016 | News story | Business Services, Research and Development, Sales and Marketing | Roche, US FDA, atezolizumab, lung cancer
Swiss drug firm Roche (SIX: ROG) on Monday said the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) and granted Priority Review for the company’s immunotherapy candidate to treat non-small cell lung cancer (NSCLC).
Atezolizumab was granted breakthrough therapy designation by the FDA in February 2015 for the treatment of NSCLC whose disease progressed during or after standard treatments. Breakthrough therapy designation is targeted at expediting the development and review of medicines intended to treat serious or life-threatening diseases.
Sandra Horning, chief medical officer and head of global product development, Roche, says: “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. The goal of PD-L1 as a biomarker is to identify people most likely to benefit from atezolizumab alone.”
The BLA submission for atezolizumab is based on results from clinical trials including a Phase II study, and the FDA will make a decision on approval by October 19, 2016.
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 to treat urothelial carcinoma (mUC).
Atezolizumab is also being studied in a number of other cancers.
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 about 60% of lung cancer diagnoses in the United States are made when the disease is in the advanced stages.
Anjali Shukla
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