Novartis AG — Votrient EMA EPAR public assessment report (EMEA/H/C/001141, 2010)
Novartis AG · 2010 · EMA EPAR public assessment report · company profile →
Report summary
This report summarizes the EMA's assessment of Votrient (pazopanib) for advanced renal cell carcinoma (RCC). Preclinical studies demonstrated pazopanib's anti-tumor activity, but also highlighted genotoxicity, embryotoxicity, and teratogenicity. Clinical pharmacology revealed non-linear pharmacokinetics and drug interactions. The pivotal Phase III study (VEG105192) showed significant improvement in progression-free survival and overall response rate compared to placebo in both treatment-naïve and cytokine-pretreated patients. Key safety concerns included hepatic dysfunction, hemorrhage, GI perforation, cardiac events, and hypertension. The CHMP recommended conditional marketing authorization, citing a positive benefit-risk balance, with post-marketing studies required for direct comparison against sunitinib. The approved indication is for first-line treatment and for patients who received prior cytokine therapy, at 800 mg once daily.
Key findings — cited to the page
| hypertension (any grade) | 38 % | · p.73 |
| vomiting (any grade) | 15 % | · p.73 |
| elevated aspartate aminotransferase (any grade) | 12 % | · p.73 |
| hair colour change (any grade) | 39 % | · p.73 |
| fatigue (any grade) | 24 % | · p.73 |
| anorexia (any grade) | 21 % | · p.73 |
| dysgeusia (any grade) | 16 % | · p.73 |
| elevated alanine aminotransferase (any grade) | 14 % | · p.73 |
| abdominal pain (any grade) | 10 % | · p.73 |
| diarrhoea (any grade) | 49 % | · p.73 |
| nausea (any grade) | 27 % | · p.73 |
| median PFS (VEG102616, IRC, adjusted for placebo) | 11.9 months | VEG102616 · p.50 |
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 →