Takeda Pharmaceutical Company Limited — Fruzaqla EMA EPAR public assessment report (EMEA/H/C/005979, 2024)
Takeda Pharmaceutical Company Limited · 2024 · EMA EPAR public assessment report · company profile →
Report summary
This EMA report details the marketing authorization application for Fruzaqla (fruquintinib) for heavily pre-treated metastatic colorectal cancer (mCRC). Fruquintinib, a VEGFR inhibitor, demonstrated a positive benefit-risk balance in the global Phase 3 FRESCO-2 trial, showing statistically significant improvements in overall survival and progression-free survival compared to placebo. The report covers extensive quality control, stability, and non-clinical assessments, including pharmacology, pharmacokinetics, and safety studies. Clinical pharmacology data, including absorption, distribution, metabolism, excretion, and drug interactions, supported the marketing authorization. While animal studies indicated fetal toxicity, the overall clinical pharmacology data, alongside the FRESCO-2 trial's efficacy and manageable safety profile, justified approval for this challenging patient population.
Key findings — cited to the page
| Grade ≥ 3 Fatigue (fruquintinib) | 3.9 % | FRESCO-2 · p.172 |
| Grade ≥ 3 Palmar-plantar erythrodysaesthesia syndrome (fruquintinib) | 6.4 % | FRESCO-2 · p.172 |
| Grade ≥ 3 Palmar-plantar erythrodysaesthesia syndrome (placebo) | 0 % | FRESCO-2 · p.172 |
| Treatment-related Grade 3 TEAEs (placebo) | 11.3 % | FRESCO-2 · p.172 |
| Grade ≥ 3 Asthenia (fruquintinib) | 7.7 % | FRESCO-2 · p.172 |
| Grade ≥ 3 Asthenia (placebo) | 3.9 % | FRESCO-2 · p.172 |
| Grade ≥ 3 TEAEs (fruquintinib) | 62.7 % | FRESCO-2 · p.172 |
| Grade ≥ 3 Hypertension (fruquintinib) | 13.6 % | FRESCO-2 · p.172 |
| Grade ≥ 3 TEAEs (placebo) | 50.4 % | FRESCO-2 · p.172 |
| Treatment-related Grade 3 TEAEs (fruquintinib) | 36.0 % | FRESCO-2 · p.172 |
| Grade ≥ 3 Hypertension (placebo) | 0.9 % | FRESCO-2 · p.172 |
| Grade ≥ 3 Fatigue (placebo) | 0.9 % | FRESCO-2 · p.172 |
Source: Takeda Pharmaceutical Company Limited ↗ · 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 →