FDA Grants Accelerated Approval to Mobocertinib for Patients With Metastatic NSCLC and EGFR Exon 20 Insertion Mutations

On September 15, the FDA granted accelerated approval to mobocertinib for adults with locally advanced or metastatic non–small cell lung cancer (NSCLC) and EGFR exon 20 insertion mutations (as detected by an FDA-approved test) whose disease has progressed on or after platinum-based chemotherapy. Mobocertinib is a small-molecule tyrosine kinase inhibitor designed to selectively target EGFR and HER2 exon 20 insertion mutations.