SOUTH SAN FRANCISCO (dpa-AFX) - Genentech, a member of Swiss drug maker Roche Holding AG (RHHBY), announced Monday that the U.S. Food and Drug Administration or FDA has accepted the company's Biologics License Application or BLA and granted Priority Review for atezolizumab.
The review is for the treatment of people with locally advanced or metastatic non-small cell lung cancer or 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.
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.
The BLA submission for atezolizumab is based on results from clinical trials including the Phase II BIRCH study. The FDA will make a decision on approval by October 19, 2016. A Premarket Application or 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.
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