The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion recommending approval of Keytruda (pembrolizumab) for the adjuvant treatment of adults with non-small cell lung cancer who are at high risk of recurrence following complete resection and platinum-based chemotherapy.
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.
