Novartis AG — Votrient EMA EPAR variation assessment report (EMEA/H/C/001141, 2010)
Novartis AG · 2010 · EMA EPAR variation assessment report · company profile →
Report summary
This report summarizes the assessment of post-marketing pediatric studies for Votrient (pazopanib) in malignant soft tissue sarcoma patients in Japan. The observational study, CPZP034B1402, included 10 pediatric and 639 adult patients. It found Votrient's safety profile in pediatric patients consistent with adults, with no new safety concerns identified. However, due to the extremely limited pediatric patient data, the findings were deemed insufficient to amend the current EU SmPC.
Key findings — cited to the page
| Procedure number | EMEA/H/C/001141/P46/039 | Votrient · p.1 |
| Study type | multicenter, uncontrolled observational study | CPZP034B1402 · Japan · p.3 |
| Approval date for malignant soft tissue sarcoma | September 2012 | Votrient · Japan · p.3 |
| Number of adult patients in safety analysis set | 639 patients | CPZP034B1402 · Japan · p.3 |
| Number of pediatric patients in safety analysis set | 10 patients | CPZP034B1402 · Japan · p.3 |
| Approval date for unresectable or metastatic renal cell carcinoma | March 17, 2014 | Votrient · Japan · p.4 |
| Percentage of patients with cardiac and vascular disorders | 8.63 % | CPZP034B1402 · p.5 |
| Percentage of patients with renal impairment | 7.70 % | CPZP034B1402 · p.5 |
| Percentage of patients with distant metastases | 81.82 % | CPZP034B1402 · p.6 |
| Starting dose of Votrient | 800 mg | CPZP034B1402 · p.6 |
| Percentage of patients with starting dose of 800 mg | 63.94 % | CPZP034B1402 · p.6 |
| Percentage of patients with hypertension | 28.04 % | CPZP034B1402 · p.5 |
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 →