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 assesses a variation application for Herceptin (trastuzumab) to include HER2-positive early breast cancer (EBC) as an additional indication, specifically in combination with neoadjuvant chemotherapy. The pivotal MO16432/NOAH study supports this application, demonstrating significant improvements in event-free and overall survival. The report also addresses safety information and risk management, including strategies for infusion-related reactions, haematotoxicity, oligohydramnios, and pulmonary disorders. While acknowledging cardiac safety risks, the overall benefit-risk balance for trastuzumab in neoadjuvant-adjuvant HER2-positive EBC is considered positive due to its substantial clinical impact.
Key findings — cited to the page
| Grade 4 neutropenia for docetaxel alone (100 mg/m2) | 76 % | · p.52 |
| Grade 3/4 neutropenia for trastuzumab and docetaxel | 32 % | · p.52 |
| increase in WHO Grade 3 or 4 haematological toxicity for trastuzumab and paclitaxel | 34 % | · p.52 |
| Grade 3/4 neutropenia for docetaxel alone | 22 % | · p.52 |
| shift of 3 or 4 grades from baseline in observation arm (HERA trial) | 0.6 % | HERA trial · p.52 |
| shift of 3 or 4 grades from baseline in trastuzumab-treated patients (HERA trial) | 0.4 % | HERA trial · p.52 |
| WHO Grade 3 leucopenia, thrombocytopenia and anaemia | < 1 % | · p.52 |
| WHO Grade 4 toxicities | 0 | · p.52 |
| increase in WHO Grade 3 or 4 haematological toxicity for paclitaxel alone | 21 % | · p.52 |
| HER2-positive patients with changed disease stage category | 59 | MO16432/NOAH · p.16 |
| Study Number | MO16432/NOAH | · p.2 |
| Patients entering post-operative phase | 84.5 % | MO16432/NOAH · p.13 |
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 →