Novartis AG — Tyverb EMA EPAR variation assessment report (EMEA/H/C/000795, 2008)
Novartis AG · 2008 · EMA EPAR variation assessment report · company profile →
Report summary
Novartis Europharm Limited submitted a Type II variation for Tyverb (lapatinib) to update its therapeutic indication. This was based on the Phase III study EGF114299 (ALTERNATIVE), which compared lapatinib plus trastuzumab plus an aromatase inhibitor (AI) against trastuzumab plus an AI, and lapatinib plus an AI, in postmenopausal patients with HR-positive, HER2-positive metastatic breast cancer previously treated with trastuzumab and endocrine therapies. The study's primary endpoint was progression-free survival. EGF114299 demonstrated a significant reduction in disease progression risk for the lapatinib+trastuzumab+AI combination compared to trastuzumab+AI, supporting the benefit of the licensed lapatinib+AI regimen. The report also detailed safety profiles, including adverse events, discontinuations, and on-treatment deaths across the treatment arms.
Key findings — cited to the page
| Paronychia (all grades) | 15 % | · p.38 |
| Nausea (all grades) | 9 % | · p.38 |
| Paronychia (all grades) | 30 % | · p.38 |
| Rash (all grades) | 28 % | · p.38 |
| Rash (all grades) | 2 % | · p.38 |
| Paronychia (all grades) | 0 % | · p.38 |
| Diarrhoea (all grades) | 69 % | · p.38 |
| Rash (all grades) | 36 % | · p.38 |
| Nausea (all grades) | 22 % | · p.38 |
| Diarrhoea (all grades) | 51 % | · p.38 |
| Diarrhoea (all grades) | 9 % | · p.38 |
| AE grade ≥3 | 35 % | · p.39 |
Source: Novartis 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 →