Ipsen S.A. — Cabometyx EMA EPAR variation assessment report (EMEA/H/C/004163, 2016)
Ipsen S.A. · 2016 · EMA EPAR variation assessment report · company profile →
Report summary
This report summarizes the CHMP's assessment of Ipsen Pharma's Type II variation for CABOMETYX (cabozantinib) to include progressive extra-pancreatic (epNET) and pancreatic (pNET) neuroendocrine tumors. The application is based on the CABINET Phase III trial, which compared cabozantinib to placebo in advanced epNET and pNET patients after prior therapy. The study demonstrated significant improvements in progression-free survival for cabozantinib in both cohorts (HR 0.38 for epNET, 0.23 for pNET). While overall survival data were immature and confounded by crossover, the safety profile was consistent with previous findings, with a higher incidence of adverse events in the cabozantinib arm. The report also reviewed non-clinical aspects and pharmacokinetic data.
Key findings — cited to the page
| Grade 3-4 AEs (all causality) for cabozantinib in epNET | 67 % | CABINET · p.145 |
| Grade 3-4 AEs (all causality) for placebo in epNET | 39 % | CABINET · p.145 |
| Grade 3/4 AEs in cabozantinib arm | 69 % | CABINET · p.143 |
| Grade 3/4 AEs in placebo arm | 41 % | CABINET · p.143 |
| Worst Grade 3 or 4 AE (cabozantinib, epNET) | 89 | CABINET · p.90 |
| Worst Grade 5 AE (cabozantinib, epNET) | 9 | CABINET · p.90 |
| Worst Grade 5 AE (placebo, epNET) | 5 | CABINET · p.90 |
| Worst Grade 3 or 4 AE (placebo, epNET) | 26 | CABINET · p.90 |
| Worst Grade 3 or 4 AE (cabozantinib, pNET) | 46 | CABINET · p.90 |
| Grade 3-4 AEs (drug-related) for placebo in pNET | 23 % | CABINET · p.145 |
| Worst Grade 3 or 4 AE (placebo, pNET) | 14 | CABINET · p.90 |
| Grade 3-4 AEs (drug-related) for cabozantinib in epNET | 59 % | CABINET · p.145 |
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 →