Pazopanib
Pazopanib (Votrient, Novartis Europharm Limited) has 3 EU-approved indications in 2 tumour types.
| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Renal cell carcinoma2 | |||
None | Monotherapy | 1L advanced | None |
None | Monotherapy | 2L advanced | After prior cytokine therapy for advanced disease |
| Soft tissue sarcoma1 | |||
None | Monotherapy | 2L advanced | After prior chemotherapy for metastatic disease or progression within 12 months after (neo)adjuvant therapy; Selective subtypes of advanced soft-tissue sarcoma |
Full text of section 4.1 (therapeutic indications)
Renal cell carcinoma (RCC) Votrient is indicated in adults for the first-line treatment of advanced renal cell carcinoma (RCC) and for patients who have received prior cytokine therapy for advanced disease. Soft-tissue sarcoma (STS) Votrient is indicated for the treatment of adult patients with selective subtypes of advanced soft-tissue sarcoma (STS) who have received prior chemotherapy for metastatic disease or who have progressed within 12 months after (neo) adjuvant therapy. Efficacy and safety has only been established in certain STS histological tumour subtypes (see section 5.1).
Label history
45 changes to the Votrient label since 2011, 1 of them to the indications. Newest first, in the words of EMA's record of each procedure.
Changes