Roche Holding AG — Perjeta EMA EPAR variation assessment report (EMEA/H/C/002547, 2013)
Roche Holding AG · 2013 · EMA EPAR variation assessment report · company profile →
Report summary
This report details a Type II variation application for Perjeta (pertuzumab) to extend its indication for neoadjuvant treatment of HER2-positive breast cancer. It outlines the design and findings of key clinical trials, NEOSPHERE and TRYPHAENA, which investigated pertuzumab in combination with trastuzumab and chemotherapy. These studies demonstrated significant improvements in pathological complete response (pCR) rates. The CLEOPATRA study, for metastatic breast cancer, showed improved progression-free and overall survival. While safety concerns included higher incidences of serious adverse events, febrile neutropenia, and diarrhea, cardiac safety was generally comparable to control arms. The overall benefit-risk balance for pertuzumab is considered positive, especially for high-risk patients.
Key findings — cited to the page
| incidence of Grade 4 neutropenia | 66.7 % | TRYPHAENA · p.78 |
| incidence of Grade 4 neutropenia | 60.2 % | NEOSPHERE · p.78 |
| incidence of Grade 4 neutropenia | 50.9 % | NEOSPHERE · p.78 |
| incidence of Grade 3-4 neutropenia | 77.0 % | TRYPHAENA · p.78 |
| incidence of Grade 4 neutropenia | 59.5 % | TRYPHAENA · p.78 |
| incidence of Grade 3-4 neutropenia | 85.3 % | TRYPHAENA · p.78 |
| incidence of Grade 3-4 neutropenia | 74.5 % | NEOSPHERE · p.78 |
| incidence of Grade 3-4 neutropenia | 84.5 % | NEOSPHERE · p.78 |
| most common NCI-CTCAE v.3 Grade 3-4 ADRs | neutropenia, febrile neutropenia and leucopenia | TRYPHAENA · p.92 |
| most common NCI-CTCAE v.3 Grade 3-4 ADR | neutropenia | NEOSPHERE · p.92 |
| most common NCI-CTCAE v.3 Grade 3-4 ADRs | neutropenia and leucopenia | TRYPHAENA · p.92 |
| most common NCI-CTCAE v.3 Grade 3-4 ADRs | neutropenia, febrile neutropenia, anaemia, leucopenia and diarrhoea | TRYPHAENA · p.92 |
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 →