Recordati B V — Fotivda EMA EPAR public assessment report (EMEA/H/C/004131, 2017)
Recordati B V · 2017 · EMA EPAR public assessment report · company profile →
Report summary
The European Medicines Agency (EMA) granted marketing authorization for Fotivda (tivozanib) for advanced renal cell carcinoma (RCC) in VEGFR pathway inhibitor-naïve patients. Tivozanib, a potent and selective VEGFR-1, -2, and -3 inhibitor, demonstrated anti-tumor efficacy in preclinical models. Pharmacokinetic studies showed dose-linear absorption and faecal excretion. The pivotal Phase 3 study (AV-951-09-301) comparing tivozanib to sorafenib showed a statistically significant improvement in median progression-free survival (11.9 vs. 9.1 months) and a higher objective response rate (33% vs. 23%) for tivozanib. Common adverse events included hypertension and dysphonia, with a lower incidence of PPE syndrome compared to sorafenib. The report also details the drug's toxicology and risk management plan.
Key findings — cited to the page
| Hypertension (Grade 1-4) in sorafenib arm | 35 % | AV-951-09-301 · p.95 |
| Hypertension (Grade 3-4) in tivozanib arm | 26 % | AV-951-09-301 · p.95 |
| Any adverse event (Grade 3-4) in tivozanib arm | 64 % | AV-951-09-301 · p.95 |
| Any adverse event (Grade 1-4) in tivozanib arm | 92 % | AV-951-09-301 · p.95 |
| Any adverse event (Grade 3-4) in sorafenib arm | 70 % | AV-951-09-301 · p.95 |
| Hypertension (Grade 1-4) in tivozanib arm | 45 % | AV-951-09-301 · p.95 |
| median duration of response by IRR | 15.0 months | AV-951-09-301 · p.92 |
| ORR by IRR | 33 % | AV-951-09-301 · p.92 |
| median duration of response by IRR for sorafenib | 12.9 months | AV-951-09-301 · p.92 |
| ORR by IRR after 16-week open-label period | 18 % | 07-201 · p.92 |
| Any adverse event (Grade 1-4) in sorafenib arm | 97 % | AV-951-09-301 · p.95 |
| Hypertension (Grade 3-4) in sorafenib arm | 18 % | AV-951-09-301 · p.95 |
Source: Recordati B V ↗ · 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 →