medwireNews: Patients with resectable, early-stage non-small-cell lung cancer (NSCLC) may be given nivolumab with platinum-doublet chemotherapy prior to surgery, the US FDA has announced.
This decision is based on results of the phase 3 CheckMate 816 trial, which showed significantly better event-free survival and pathologic complete response with the addition of nivolumab to platinum-doublet chemotherapy.
The FDA statement notes that this is the first neoadjuvant therapy approved for use in early-stage NSCLC in the USA, and the recommended dose of nivolumab is 360 mg every 3 weeks for three cycles given alongside platinum-doublet chemotherapy on the same day.
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