Roche’s VENTANA PD-L1 (SP263) Assay has received CE IVD approval to identify patients with locally advanced and metastatic NSCLC eligible for Libtayo, based on results of the phase III EMPOWER-Lung 1.
FDA has accepted a New Drug Application for zipalertinib for the treatment of patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy, with or without amivantamab. The Prescription Drug User Fee Act target action date is Feb. 27, 2027.
