Ipsen S.A. — Cabometyx EMA EPAR public assessment report (EMEA/H/C/004163, 2016)
Ipsen S.A. · 2016 · EMA EPAR public assessment report · company profile →
Report summary
The EMA approved CABOMETYX (cabozantinib) for advanced renal cell carcinoma (RCC) via accelerated assessment due to unmet medical needs. This oral multiple receptor tyrosine kinase inhibitor, previously approved as Cometriq, demonstrated acceptable quality and non-clinical safety, though reproductive toxicity was noted in animal models. The tablet and capsule formulations are not interchangeable. Pharmacokinetic studies established the 60 mg dose as optimal despite frequent dose reductions. The pivotal XL184-308 Phase 3 trial compared Cabometyx to Everolimus, showing significant clinical benefit in progression-free survival, overall survival, and objective response rate. Post-marketing requirements include safety reporting and a post-authorisation efficacy study to confirm survival advantage.
Key findings — cited to the page
| Percentage of patients with metastatic disease at diagnosis | 30 % | · p.10 |
| Approval date for Opdivo (nivolumab) for advanced RCC | 19/06/2015 | Opdivo · EC · p.11 |
| Estimated 5-year prevalence of RCC | 229,465 cases | EU-28, Iceland, Norway · p.9 |
| Percentage of RCCs detected incidentally | 50 % | · p.10 |
| 5-year survival rate for mRCC patients | 8% to 22.5% | · p.10 |
| 5-year survival rate for localized renal cancer patients | 90 % | · p.10 |
| Approval date for Cometriq capsules (medullary thyroid carcinoma) | March 2014 | Cometriq · EU · p.9 |
| first periodic safety update report submission | 6 months following authorisation | Union · p.119 |
| PAES submission due date | September 2017 | XL184-308 · p.119 |
| trial phase | 3 | XL184-308 · p.119 |
| clinical benefit | significant | · p.119 |
| Recommended dose of Afinitor for advanced RCC | 10 mg | Afinitor · p.11 |
Source: Ipsen S.A. ↗ · 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 →