Merck & Co., Inc. — Keytruda EMA EPAR variation assessment report (EMEA/H/C/003820, 2015)
Merck & Co., Inc. · 2015 · EMA EPAR variation assessment report · company profile →
Report summary
Merck Sharp & Dohme B.V. submitted a Type II variation application to the EMA for Keytruda (pembrolizumab) subcutaneous formulation. This application aims to extend the indication to adolescents aged 12 years and older for melanoma and classical Hodgkin lymphoma. The approval relies on an extrapolation approach from adult data and existing intravenous formulation approvals in paediatrics, supported by pharmacokinetic modeling and simulation demonstrating comparable exposure levels between adolescents and adults. The report also details the updated risk management plan and safety concerns associated with pembrolizumab.
Key findings — cited to the page
| Subcutaneous dose of pembrolizumab | 790 mg | Keytruda SC · p.26 |
| CHMP opinion date | 21 May 2026 | · p.6 |
| Age for Hodgkin Lymphoma indication (IV) | 3 years and older | Keytruda · p.22 |
| Age for melanoma indication (IV) | 12 years and older | Keytruda · p.22 |
| RMP version | 48.0 | · p.23 |
| Age for Keytruda IV in Hodgkin lymphoma | 3 years and older | Keytruda · p.25 |
| Age for Keytruda SC extension of indication | 12 years and older | Keytruda SC · p.25 |
| Weight for Keytruda SC extension of indication | 40 kg | Keytruda SC · p.26 |
| Subcutaneous dose of pembrolizumab | 395 mg | Keytruda SC · p.26 |
| Application submission date | 02 December 2025 | Keytruda · p.5 |
| Pembrolizumab terminal half-life at steady-state | 22 days | Pembrolizumab · p.10 |
| Pembrolizumab systemic accumulation (Q3W) | 2.1 fold | Pembrolizumab · p.10 |
Source: Merck & Co., Inc. ↗ · 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 →