FDA has granted premarket approval to Thermo Fisher Scientific’s Oncomine Dx Target Test as a companion diagnostic to help identify non-small cell lung cancer patients whose tumors carry epidermal growth factor receptor Exon20-insertion mutations for potential treatment with Rybrevant (amivantamab-vmjw), Janssen Biotech Inc.’s targeted therapy.
FDA approved Rybrevant (amivantamab-vmjw) plus Lazcluze (lazertinib) for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test.
