Votrient(pazopanib)
Oncology· 359 cited findings· 2 source documents
Company: Novartis AG →
What the regulatory reviews say
Votrient (pazopanib) is indicated for the first-line treatment of advanced Renal Cell Carcinoma (RCC) and for patients who have received prior cytokine therapy for advanced disease. It received Orphan Medicinal Product designation (EU/3/06/382) due to the prevalence of RCC being 3.5 per 100,000 EU population. The recommended dose of pazopanib is 800 mg once daily.
In efficacy studies, pazopanib demonstrated an OS HR of 0.74 when compared to placebo in first-line treatment. The median Progression-Free Survival (PFS) was 11.9 months (IRC, adjusted for placebo) and 9.9 months (investigator, adjusted for placebo) in the VEG102616 study. In the VEG107769 study, the median PFS was 8.3 months (investigator assessment) with a 95% CI of 6.1 to 11.4, and the median OS was 16.8 months. The Overall Response Rate (ORR) was 32% in the VEG107769 study.
Safety findings include an increase in pazopanib AUC0-t by 120% and Cmax by 50% when co-administered with ketoconazole. Conversely, co-administration with CYP3A4 inducing anticonvulsants led to a 30% reduction in mean pazopanib AUC0-24h and a 50% reduction in mean pazopanib C24. Pazopanib also increased midazolam AUC and Cmax by 30-35% and paclitaxel mean AUCinf by 26%.
Key figures — cited to the source page
| OS HR (Pazopanib 1L vs Placebo) | 0.74 | Novartis AG — Votrient EMA EPAR public assessment report (EM, p.48 |
| median PFS (VEG102616, IRC, adjusted for placebo) | 11.9 | Novartis AG — Votrient EMA EPAR public assessment report (EM, p.50 |
| median OS (VEG107769) | 16.8 | Novartis AG — Votrient EMA EPAR public assessment report (EM, p.50 |
| ORR (VEG107769) | 32 | Novartis AG — Votrient EMA EPAR public assessment report (EM, p.50 |
| Increase in AUC0-t with ketoconazole co-administration | 120 | Novartis AG — Votrient EMA EPAR public assessment report (EM, p.28 |
| Reduction in mean pazopanib AUC0-24h with CYP3A4 inducing anticonvulsants | 30 | Novartis AG — Votrient EMA EPAR public assessment report (EM, p.28 |
| Approved indication for Votrient | first line treatment of advanced Renal Cell Carcinoma (RCC) and for patients who have received prior cytokine therapy for advanced disease | Novartis AG — Votrient EMA EPAR public assessment report (EM, p.5 |
| pazopanib recommended dose | 800 | Novartis AG — Votrient EMA EPAR public assessment report (EM, p.51 |
Source documents
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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.