Daiichi-AstraZeneca's Flagship Cancer Drug Scores FDA Approval For Lung Cancer Harboring HER2 Mutation

  • The FDA has approved Daiichi Sankyo DSNKY and AstraZeneca plc's AZN Enhertu (fam-trastuzumab deruxtecan-nxki) for unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations.
  • This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DoR). 
  • Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
  • The accelerated approval by the FDA was based on the results from the DESTINY-Lung02 phase 2 trial. 
  • Interim efficacy analysis showed that Enhertu demonstrated a confirmed ORR of 57.7%. Complete responses were seen in 1.9% of patients and partial responses in 55.8%, with a median duration of response of 8.7 months.
  • Following approval in the U.S., $125 million is due from AstraZeneca to Daiichi Sankyo as a milestone payment for a second-line indication for Enhertu in HER2 mutant NSCLC.
  • Concurrently, the FDA has approved Guardant Health Inc's GH Guardant360 CDx liquid biopsy test as a companion diagnostic for Enhertu for NSCLC patients with activating HER2 mutations.
  • Price Action: AZN shares are up 0.84% at $65.19 during the market session on the last check Friday.
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