FDA has approved for FoundationOne CDx to be used as a companion diagnostic to identify patients with non-small cell lung cancer whose tumors have epidermal growth factor receptor exon 19 deletions or exon 21 (L858R) alterations and are appropriate for treatment with EGFR tyrosine kinase inhibitors approved by FDA for this indication.
FDA approved Opdivo (nivolumab) with platinum-doublet chemotherapy as neoadjuvant treatment, followed by single-agent Opdivo after surgery as adjuvant treatment, for adults with resectable (tumors ≥ 4 cm and/or node positive) non-small cell lung cancer and no known epidermal growth factor receptor mutations or anaplastic lymphoma kinase rearrangements.
