Daiichi Sankyo Company, Limited — Enhertu EMA EPAR public assessment report (EMEA/H/C/005124, 2021)
Daiichi Sankyo Company, Limited · 2021 · EMA EPAR public assessment report · company profile →
Report summary
The EMA granted conditional marketing authorization for Enhertu (trastuzumab deruxtecan) for unresectable/metastatic HER2-positive breast cancer, citing high unmet medical need. Clinical data from Study U201 showed significant objective response rates (61.4%) and durable responses (median 20.8 months) in heavily pre-treated patients, with a median overall survival of 24.6 months. Non-clinical studies confirmed specific HER2 binding and superior antitumor activity. While demonstrating therapeutic advantages, Enhertu's safety profile includes a high incidence of adverse events, notably interstitial lung disease/pneumonitis, and potential embryotoxicity. Ongoing Phase 3 trials will provide confirmatory efficacy and safety data.
Key findings — cited to the page
| TEAEs with Worst CTCAE ≥Grade 3 | 54.7 % | HER2-positive BC 5.4 mg/kg Pool · p.164 |
| drug-related TEAEs with Worst CTCAE ≥Grade 3 | 45.7 % | HER2-positive BC 5.4 mg/kg Pool · p.164 |
| Grade 3+ febrile neutropenia | 6.6 % | · p.186 |
| increase in Grade 3 or greater ILD events at 360-d incidence (5.4 to 6.4 mg/kg) | 1.6 % | · p.103 |
| Grade 3+ fatigue | 13.1 % | · p.186 |
| Grade 3+ fatigue | 2.9 % | · p.186 |
| increase in Grade ≥3 AEs incidence (5.4 to 6.4 mg/kg) | 6.9 % | · p.103 |
| Grade ≥3 AEs rate | 49.4 % | · p.103 |
| increase in Grade ≥2 ECHO LVEF reductions incidence (5.4 to 6.4 mg/kg) | 4.0 % | · p.103 |
| Grade 3+ TEAEs | 62.3 % | · p.186 |
| Grade 3+ TEAEs | 52.0 % | · p.186 |
| Grade 3+ febrile neutropenia | 0 % | · p.186 |
Source: Daiichi Sankyo Company, Limited ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →