DAIICHI SANKYO — Enhertu FDA Review (NDA/BLA 761139, 2023)
Daiichi Sankyo Company, Limited · 2023 · FDA Review (Drugs@FDA) · company profile →
Report summary
The FDA approved Enhertu (fam-trastuzumab deruxtecan-nxki) on August 11, 2022, for multiple indications, including HER2-positive/low metastatic breast cancer, HER2-mutant non-small cell lung cancer (NSCLC) (accelerated approval), and HER2-positive gastric/gastroesophageal junction adenocarcinoma. Efficacy data from trials like DESTINY-Lung02 and DESTINY-Lung01 showed significant improvements in objective response rates and progression-free survival across indications. For HER2-mutant NSCLC, the 5.4 mg/kg dose demonstrated consistent efficacy (ORR 58%) with reduced toxicity compared to the 6.4 mg/kg dose. The safety profile highlights adverse reactions such as interstitial lung disease (ILD)/pneumonitis (6% at 5.4 mg/kg vs. 14-26% at 6.4 mg/kg), neutropenia, and left ventricular dysfunction (rare). The FDA recommended accelerated approval for the 5.4 mg/kg dose in HER2-mutant NSCLC due to its favorable benefit-risk profile, with post-marketing studies required for confirmation.
Key findings — cited to the page
| Grade ≥3 TEAEs (Study U204 HER2 mutant NSCLC) | 69% | Study U204 (DESTINY-Lung01) · p.335 |
| Grade ≥3 ILD or pneumonitis (Study U204 HER2 mutant NSCLC) | 6 patients | Study U204 (DESTINY-Lung01) · p.335 |
| Vomiting (All Grades) in ENHERTU arm | 49 % | DESTINY-Breast03 · p.19 |
| Nausea (All Grades) in ENHERTU arm | 76 % | DESTINY-Breast03 · p.19 |
| Nausea (All Grades) in Ado-trastuzumab emtansine arm | 30 % | DESTINY-Breast03 · p.19 |
| Nausea (Grades 3-4) in Ado-trastuzumab emtansine arm | 0.4 % | DESTINY-Breast03 · p.19 |
| Grade 3 LVEF decrease incidence in metastatic breast cancer and HER2-mutant NSCLC | 0.4 % | · p.17 |
| Vomiting (Grades 3-4) in Ado-trastuzumab emtansine arm | 0.8 % | DESTINY-Breast03 · p.19 |
| Grade 3 or 4 decreased neutrophil count incidence in gastric cancer | 51 % | · p.17 |
| Asymptomatic Grade 2 LVEF decrease incidence in gastric cancer | 8 % | · p.17 |
| Constipation (All Grades) in ENHERTU arm | 34 % | DESTINY-Breast03 · p.19 |
| Grade 3 or 4 decreased neutrophil count incidence in metastatic breast cancer and HER2-mutant NSCLC | 16 % | · p.17 |
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 →