Ipsen S.A. — Cometriq EMA EPAR public assessment report (EMEA/H/C/002640, 2014)
Ipsen S.A. · 2014 · EMA EPAR public assessment report · company profile →
Report summary
The EMA granted conditional Marketing Authorisation for Cometriq (cabozantinib) for progressive, unresectable locally advanced or metastatic medullary thyroid carcinoma (MTC), recognizing its orphan drug status and unmet medical need. Non-clinical studies detailed its multi-kinase inhibition, pharmacokinetics, and toxicology, identifying target organs. Clinical pharmacology confirmed its mechanism and pharmacokinetic profile. The pivotal Phase III XL184-301 study demonstrated a statistically significant improvement in progression-free survival (PFS) and objective response rate (ORR) compared to placebo, with a later updated overall survival (OS) showing a median of 26 months versus 20.3 months. However, cabozantinib was associated with a high incidence of Grade 3/4 adverse events, leading to frequent dose reductions. The safety profile and risk management plan address these concerns, with ongoing studies planned to optimize dosing and further assess the impact of RET mutation status. The positive benefit-risk balance supported conditional approval.
Key findings — cited to the page
| grade 3 or higher fatigue (placebo arm) | 2.8 % | XL184-301 · p.72 |
| grade 3 or higher fatigue (cabozantinib arm) | 9.3 % | XL184-301 · p.72 |
| grade 3 or higher decreased appetite (cabozantinib arm) | 4.7 % | XL184-301 · p.72 |
| grade 3 or higher weight loss (placebo arm) | 0 % | XL184-301 · p.72 |
| grade 3 or higher nausea (cabozantinib arm) | 1.4 % | XL184-301 · p.72 |
| grade 3 or higher nausea (placebo arm) | 0 % | XL184-301 · p.72 |
| treatment related grade 3 or 4 TEAEs (placebo arm) | 19.3 % | XL184-301 · p.70 |
| treatment related grade 3 or 4 TEAEs (cabozantinib arm) | 64.0 % | XL184-301 · p.70 |
| grade 3 or 4 TEAEs (cabozantinib arm) | 64.0 % | XL184-301 · p.71 |
| grade 3 or higher weight loss (cabozantinib arm) | 4.7 % | XL184-301 · p.72 |
| grade 3 or higher decreased appetite (placebo arm) | 0.9 % | XL184-301 · p.72 |
| grade 3 or higher dyspnoea (cabozantinib arm) | 2.3 % | XL184-301 · p.72 |
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 →