Roche Holding AG — Kadcyla EMA EPAR public assessment report (EMEA/H/C/002389, 2013)
Roche Holding AG · 2013 · EMA EPAR public assessment report · company profile →
Report summary
This report summarizes the EMA's assessment of Kadcyla (trastuzumab emtansine) for HER2-positive metastatic breast cancer. It details the drug's manufacturing, quality control, and non-clinical profile, including pharmacology, pharmacokinetics, and toxicology, confirming its safety and mechanism as an antibody-drug conjugate. Clinical trials established its pharmacokinetics and recommended dose. The pivotal Phase III EMILIA study demonstrated superior efficacy, with significantly improved progression-free and overall survival compared to lapatinib plus capecitabine. Safety data highlighted common adverse events and specific toxicities like hepatotoxicity and thrombocytopenia, which were manageable. The CHMP recommended marketing authorization based on a positive benefit-risk balance, with post-authorization studies planned to further evaluate safety and efficacy.
Key findings — cited to the page
| abdominal pain (Grade 1-5) | 9 % | Total trastuzumab emtansine-exposed · p.83 |
| abdominal pain (Grade 1-2) | 8 % | Total trastuzumab emtansine-exposed · p.83 |
| abdominal pain (Grade 3-5) | 1 % | Total trastuzumab emtansine-exposed · p.83 |
| any adverse event (Grade 3-5) | 33 % | Total trastuzumab emtansine-exposed · p.83 |
| abdominal pain upper (Grade 3-5) | 0 % | Total trastuzumab emtansine-exposed · p.83 |
| abdominal pain upper (Grade 1-5) | 11 % | Total trastuzumab emtansine-exposed · p.83 |
| patients with AE NCI-CTC Grade ≥ 3 | 40.8 % | TDM4370g/BO21977 · p.82 |
| any adverse event (Grade 1-5) | 95 % | Total trastuzumab emtansine-exposed · p.83 |
| patients with AE NCI-CTC Grade ≥ 3 | 57 % | TDM4370g/BO21977 · p.82 |
| any adverse event (Grade 1-2) | 62 % | Total trastuzumab emtansine-exposed · p.83 |
| abdominal pain upper (Grade 1-2) | 10 % | Total trastuzumab emtansine-exposed · p.83 |
| alopecia (Grade 1-2) | 3 % | Total trastuzumab emtansine-exposed · p.83 |
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 →