Daiichi Sankyo Company, Limited — Enhertu FDA Review (BLA761139, ORIG 1, 2019)
Daiichi Sankyo Company, Limited · 2019 · FDA Review (openFDA) · company profile →
Report summary
The FDA granted accelerated approval for Daiichi Sankyo's Enhertu (fam-trastuzumab deruxtecan-nxki) for unresectable or metastatic HER2-positive breast cancer in patients who received two or more prior anti-HER2 regimens. Efficacy, primarily from the DESTINY-Breast-01 trial, showed a 60.3% objective response rate and 14.8-month median duration of response. The drug acts as a HER2-directed antibody and topoisomerase inhibitor conjugate. Significant safety concerns include serious adverse reactions in 20% of patients and fatalities in 4.3%, with interstitial lung disease (ILD) being a critical safety signal (9.4% incidence, 2.6% fatal), warranting a boxed warning. The recommended dose is 5.4 mg/kg Q3W, balancing efficacy and safety. Postmarketing studies are required.
Key findings — cited to the page
| Drug-related ILD Grade 3 | 1.2 % | ENHERTU (fam-trastuzumab deruxtecan-nxki) · p.195 |
| Grade ≥3 AEs | 40.8 % | EMILIA study · p.31 |
| all grade anemia | 31% | · p.185 |
| Drug-related ILD Grade 2 | 7.4 % | ENHERTU (fam-trastuzumab deruxtecan-nxki) · p.195 |
| Drug-related ILD Grade 5 | 1.9 % | ENHERTU (fam-trastuzumab deruxtecan-nxki) · p.195 |
| IRR events (Grade 1 or 2) | 6 subjects | · p.201 |
| Grade ≥3 AEs | 32 % | TH3RESA study · p.31 |
| Grade 5 AEs | 1 % | TH3RESA study · p.31 |
| White blood cell count decreased (Any CTCAE Grade) | 70.1 % | ENHERTU (fam-trastuzumab deruxtecan-nxki) · p.190 |
| Drug-related ILD Grade 1 | 6.6 % | ENHERTU (fam-trastuzumab deruxtecan-nxki) · p.195 |
| Drug-related ILD Grade 4 | 0.8 % | ENHERTU (fam-trastuzumab deruxtecan-nxki) · p.195 |
| Grade ≥3 AEs | 57 % | EMILIA study · p.31 |
Source: Daiichi Sankyo Company, Limited ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →