AstraZeneca and Daiichi Sankyo’s Enhertu Wins Historic FDA Approval as First Tumor-Agnostic HER2-Directed Therapy

1. Enhertu (fam-trastuzumab deruxtecan-nxki) has been approved by the FDA as the first tumor-agnostic HER2-directed therapy for previously treated patients with unresectable or metastatic HER2-positive solid tumors.
2. The approval is based on three Phase II trials, including DESTINY-Lung01, DESTINY-CRC02, and DESTINY-PanTumor02, which demonstrated clinically meaningful responses.
3. Enhertu is a specifically engineered HER2-directed antibody-drug conjugate (ADC) jointly developed and commercialized by AstraZeneca and Daiichi Sankyo.
4. The approval was granted under the accelerated approval program, with continued approval contingent upon verification and description of clinical benefit in a confirmatory study.
5. Enhertu has five approved indications, with the latest in HER2-expressing (IHC 3+) metastatic cancers.
6. Enhertu is also approved for advanced or metastatic HER2-positive gastric cancer, previously treated HER2-mutant metastatic non-small cell lung cancer, and metastatic HER2-positive and HER2-low breast cancer.
7. The approval was reviewed under the Real-Time Oncology Review program and Project Orbis, which aim to bring safe and effective cancer treatments to patients quickly.