Based on the phase II randomized DESTINY-LUNG02 trial, which showed an ORR of 53.8% in previously treated HER2-mutant NSCLC (NCT04644237) [135], the FDA has recently granted accelerated approval to DS-8201 for treatment of previously treated HER2-mutant NSCLC. The gene discussed is ERBB2; the disease is non-small cell lung carcinoma.