US FDA approval of AstraZeneca PLC's Imfinzi (durvalumab) for non-small cell lung cancer is important in two big respects – it is the drug's first clearance in this valuable tumor type and it is the first in such an early line of therapy for a PD-1/L1 inhibitor.
FDA announced approval of Imfinzi on Feb. 16 for patients with Stage III non-small cell lung cancer (NSCLC) whose tumors may not be surgically removed (unresectable) and who did not progress after treatment with concurrent chemotherapy and radiation, in order to reduce the risk of advancing. AstraZeneca's PD-L1 has a lead over its competitors in this early stage of NSCLC and may have the field to itself for a few years
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