Roche Holding AG — Perjeta EMA EPAR public assessment report (EMEA/H/C/002547, 2013)
Roche Holding AG · 2013 · EMA EPAR public assessment report · company profile →
Report summary
The EMA's assessment of Perjeta (pertuzumab) for HER2-positive metastatic breast cancer led to a CHMP recommendation for authorization in December 2012. The report details the manufacturing process, quality control, and non-clinical pharmacology, highlighting pertuzumab's mechanism of action and anti-tumor efficacy, with dose-dependent diarrhea as a key non-clinical finding. Pharmacokinetic analysis and reproductive toxicity studies informed usage recommendations. The pivotal CLEOPATRA Phase III study demonstrated significant improvements in progression-free and overall survival when pertuzumab was combined with trastuzumab and docetaxel. Safety data from this trial, including adverse events like cardiac toxicity, infusion reactions, and neutropenia, were thoroughly evaluated. Despite safety concerns in specific populations, the overall benefit-risk balance was deemed positive, supporting marketing authorization.
Key findings — cited to the page
| Grade >= 3 Neutropenia | 45.8 % | WO20698 · p.101 |
| Grade >= 3 leucopenia | 58.2 % | WO20698 · p.101 |
| Grade >= 3 AE on the day of or the day after a placebo/pertuzumab infusion | 14.9 % | WO20698 · p.100 |
| Grade >= 3 AE on the day of a placebo/pertuzumab infusion | 12.3 % | WO20698 · p.100 |
| Grade >= 3 AE on the day of or the day after a placebo/pertuzumab infusion | 16.5 % | WO20698 · p.100 |
| Grade >= 3 leucopenia | 53.1 % | WO20698 · p.101 |
| Diarrhoea (Grade >= 3) | 7.9 % | WO20698 · p.102 |
| Grade >= 3 AE starting during a placebo/pertuzumab infusion | 0.2 % | WO20698 · p.100 |
| Grade 3 or higher LVSD | 1.2 % | WO20698 · p.96 |
| Grade >= 3 AE on the day of a placebo/pertuzumab infusion | 10.6 % | WO20698 · p.100 |
| Grade 3 or higher LVSD | 2.8 % | WO20698 · p.96 |
| Grade >= 3 Neutropenia | 48.9 % | WO20698 · p.101 |
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 →