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www.fdanews.com/articles/176220-roches-cancer-candidate-snags-priority-review
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Roche’s Cancer Candidate Snags Priority Review

April 15, 2016

The FDA has granted priority review for Roche’s atezolizumab in patients with locally advanced or metastatic non-small lung cancer whose disease expresses programmed death ligand-1 and whose disease has progressed following chemotherapy.

The FDA granted the cancer immunotherapy breakthrough designation in February 2015 for this indication.

The company notes that this is the candidate’s second priority review. The FDA previously granted priority review for patients with locally advanced or metastatic urothelial carcinoma with disease progression during or after chemotherapy or who had experienced a worsening of the disease within 12 months of undergoing chemotherapy and surgery.