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.