Novartis AG — Tyverb EMA EPAR public assessment report (EMEA/H/C/000795, 2008)
Novartis AG · 2008 · EMA EPAR public assessment report · company profile →
Report summary
This report summarizes the European regulatory process for Tyverb (lapatinib), a dual tyrosine kinase inhibitor for ErbB1 and ErbB2, which received conditional Marketing Authorisation in April 2008 due to its favorable risk-benefit balance despite ongoing safety analyses. Non-clinical studies detailed its pharmacology, pharmacokinetics (high protein binding, CYP3A4/5 metabolism), and toxicity (skin/GI effects, reproductive concerns). Clinical trials, particularly the pivotal Phase III study (EGF100151), demonstrated improved objective response rates and progression-free survival when lapatinib was combined with capecitabine in HER2-positive metastatic breast cancer, though overall survival benefit was not statistically significant. Common adverse events included diarrhea and rash, with hepatotoxicity and decreased LVEF also noted. The CHMP acknowledged the unmet medical need and recommended conditional approval, requiring further data on CNS metastases and overall survival.
Key findings — cited to the page
| grade 4 Diarrhea in Lapatinib+Capecitabine group | 1 % | EGF100151 · p.42 |
| grade 3 Vomiting in Lapatinib+Capecitabine group | 2 % | EGF100151 · p.42 |
| grade 3 Any event in Lapatinib+Capecitabine group | 43 % | EGF100151 · p.42 |
| grade 3 Diarrhea in Lapatinib+Capecitabine group | 13 % | EGF100151 · p.42 |
| grade 3 Nausea in Lapatinib+Capecitabine group | 2 % | EGF100151 · p.42 |
| grade 3 Fatigue in Lapatinib+Capecitabine group | 3 % | EGF100151 · p.42 |
| mean duration of grade 3/4 AEs prior to progression in lapatinib + capecitabine group | 1.7 weeks | · p.37 |
| mean duration of grade 3/4 AEs prior to progression in capecitabine group | 1.5 weeks | · p.37 |
| grade 4 Any event in Lapatinib+Capecitabine group | 6 % | EGF100151 · p.42 |
| grade 5 Any event in Lapatinib+Capecitabine group | <1 % | EGF100151 · p.42 |
| grade 3 PPE syndrome in Lapatinib+Capecitabine group | 12 % | EGF100151 · p.42 |
| grade 3 Rash in Lapatinib+Capecitabine group | 2 % | EGF100151 · p.42 |
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 →