Fruzaqla(fruquintinib)
Oncology· 393 cited findings· 1 source document
What the regulatory reviews say
Fruzaqla (fruquintinib) is a drug for which an application was submitted on 25 May 2023, following an EMA/CHMP eligibility agreement on 22 July 2021. Its International Birth Date is 04.09.2018, and it is currently under additional monitoring status.
In a Phase 3 trial with 934 patients, Fruzaqla demonstrated a median overall survival of 7.4 months (95% CI: 6.7-8.2 months) compared to 4.8 months for placebo, representing a 34% reduction in the risk of death (HR: 0.662, 95% CI: 0.549-0.800, p-value: <0.001). Patients in this trial had a median of 4 prior anticancer treatment lines, with 96.4% having received prior anti-VEGF treatment and 39.4% having received both trifluridine-tipiracil and regorafenib.
Safety data from pooled placebo-controlled studies (total N=1172 patients) showed that 98.9% of patients on fruquintinib experienced any treatment-emergent adverse event (TEAE), compared to 92.6% on placebo. Grade ≥ 3 TEAEs occurred in 62.7% of fruquintinib patients, while 50.4% of placebo patients experienced them. Adverse events of special interest (AESIs) were reported in 80.7% of fruquintinib patients.
Key figures — cited to the source page
| Median overall survival (fruquintinib) | 7.4 | Takeda Pharmaceutical Company Limited — Fruzaqla EMA EPAR pu, p.171 |
| Median overall survival (placebo) | 4.8 | Takeda Pharmaceutical Company Limited — Fruzaqla EMA EPAR pu, p.171 |
| Reduction in risk of death | 34 | Takeda Pharmaceutical Company Limited — Fruzaqla EMA EPAR pu, p.171 |
| Any TEAE (fruquintinib) | 98.9 | Takeda Pharmaceutical Company Limited — Fruzaqla EMA EPAR pu, p.172 |
| Any TEAE (placebo) | 92.6 | Takeda Pharmaceutical Company Limited — Fruzaqla EMA EPAR pu, p.172 |
| Grade ≥ 3 TEAEs (fruquintinib) | 62.7 | Takeda Pharmaceutical Company Limited — Fruzaqla EMA EPAR pu, p.172 |
| Application submission date | 25 May 2023 | Takeda Pharmaceutical Company Limited — Fruzaqla EMA EPAR pu, p.11 |
| Additional monitoring status | included | Takeda Pharmaceutical Company Limited — Fruzaqla EMA EPAR pu, p.168 |
Source documents
Explore the full evidence
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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.