Tyverb(lapatinib)
Oncology· 552 cited findings· 2 source documents
Company: Novartis AG →
What the regulatory reviews say
Tyverb (lapatinib) is an oncology drug. The Marketing Authorisation application was submitted on 4 October 2006, leading to a CHMP positive opinion for conditional Marketing Authorisation on 13 December 2007, and a revised opinion on 24 April 2008. Lapatinib received US approval on 13-Mar-2007 and EU approval on 10-Jun-2008.
In preclinical studies, lapatinib demonstrated efficacy with an IC50 for ErbB1 inhibition of 9.2 nM and ErbB2 inhibition of 10.8 nM. It showed complete tumour growth suppression at 100 mg/kg in the BT474 mouse xenograft model and 93% reduction in phosphorylation at 150 mg/kg for 3 days in the HN5 mouse xenograft model. In a Phase III study, the clinical benefit rate (CBR) for the lapatinib+trastuzumab+AI arm was 41%, with a PFS INV (HR) of 0.62.
Notable safety findings from the clinical trials include decreased appetite (18%), stomatitis (17%), ASAT (6%), and ALAT (7%).
Key figures — cited to the source page
| IC50 for ErbB1 inhibition | 9.2 | Novartis AG — Tyverb EMA EPAR public assessment report (EMEA, p.9 |
| IC50 for ErbB2 inhibition | 10.8 | Novartis AG — Tyverb EMA EPAR public assessment report (EMEA, p.9 |
| Reduction in phosphorylation at 150 mg/kg for 3 days in HN5 mouse xenograft model | 93 | Novartis AG — Tyverb EMA EPAR public assessment report (EMEA, p.10 |
| PFS INV (HR) | 0.62 | Novartis AG — Tyverb EMA EPAR variation assessment report (E, p.38 |
| Clinical benefit rate (CBR) for L+T+AI arm | 41 | Novartis AG — Tyverb EMA EPAR variation assessment report (E, p.21 |
| Decreased appetite | 18 | Novartis AG — Tyverb EMA EPAR variation assessment report (E, p.39 |
| Stomatitis | 17 | Novartis AG — Tyverb EMA EPAR variation assessment report (E, p.39 |
| Lapatinib EU approval date | 10-Jun-2008 | Novartis AG — Tyverb EMA EPAR variation assessment report (E, p.5 |
Source documents
Explore the full evidence
All 552 cited findings for Tyverb — searchable, comparable and answerable in plain language — are in the Oncology research library →
Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.