Roche Holding AG — Herceptin EMA EPAR variation assessment report (EMEA/H/C/000278, 2000)
Roche Holding AG · 2000 · EMA EPAR variation assessment report · company profile →
Report summary
This report details the CHMP assessment of Roche's variation application for Herceptin (trastuzumab), introducing a new 600 mg/5 mL subcutaneous formulation for HER2-positive metastatic and early breast cancer. The application includes product information, quality aspects, and the novel excipient rHuPH20. Non-clinical and clinical studies, including the Phase III HANNAH trial, demonstrated non-inferiority of the subcutaneous formulation compared to intravenous trastuzumab in terms of pharmacokinetics (trough concentration and AUC) and efficacy (pathological complete response). While the subcutaneous formulation showed a higher incidence of anti-trastuzumab antibodies and some adverse events, the overall benefit-risk balance was deemed positive. The CHMP recommended granting the extension of the marketing authorization.
Key findings — cited to the page
| Grade ≥ 3 cardiac AEs | 1.0 % | BO22227 · p.67 |
| Grade ≥ 3 cardiac AEs | 1.7 % | BO22227 · p.67 |
| inter-individual variability for CL (before covariate inclusion) | 28.9 % | BO22227 · p.35 |
| Strength | 600 mg / 5 mL | Herceptin · p.3 |
| Application submission date | 1 March 2012 | · p.7 |
| Route of administration | Subcutaneous use | Herceptin · p.3 |
| Vc | 2.89 L | BO22227 · p.35 |
| number of patients | 596 | BO22227 (HannaH) · p.32 |
| Pharmaco-therapeutic group (ATC Code) | L01XC03 | Herceptin · p.2 |
| Pharmaceutical form | Solution for injection | Herceptin · p.3 |
| Package size | 1 vial | Herceptin · p.3 |
| Procedure Number | EMEA/H/C/000278 | Herceptin · p.1 |
Source: Roche Holding AG ↗ · 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 →