Servier — Tibsovo EMA EPAR public assessment report (EMEA/H/C/005936, 2023)
Servier · 2023 · EMA EPAR public assessment report
Report summary
Servier's Tibsovo (ivosidenib) received EMA marketing authorization for IDH1-mutated cholangiocarcinoma (monotherapy) and newly diagnosed IDH1-mutated AML (with azacitidine) in patients ineligible for intensive chemotherapy. The application, supported by orphan medicinal product designations, detailed Tibsovo's selective IDH1 inhibition, manufacturing, and non-clinical toxicology, including resolved nitrosamine concerns and QTc prolongation. Clinical trials (AG120-C-005 for cholangiocarcinoma and AG120-C-009 for AML) demonstrated significant improvements in progression-free survival, overall survival, and response rates. Safety profiles highlighted manageable adverse events, with specific attention to QT prolongation, differentiation syndrome, and embryo-foetal toxicity, all addressed in the risk management plan.
Key findings — cited to the page
| incidence of Grade ≥3 TEAEs in placebo arm | 37.3 % | pivotal study · p.158 |
| incidence of Grade ≥3 TEAEs in ivosidenib arm | 51.2 % | pivotal study · p.158 |
| IDH1 mutations in Grade 2 to 3 gliomas | 70 % | · p.13 |
| incidence of Grade >=3 TEAEIs of infection | 21.1 % | · p.225 |
| overall incidence of Infections of any grade | 30.6 % | · p.225 |
| overall incidence of Infections of any grade | 51.4 % | · p.225 |
| incidence of grade 3 ECG QT prolongation | 9 % | AG120-C-001 · p.223 |
| Grade ≥ 3 QT prolongation events (cholangiocarcinoma) | 2.2 % | · p.75 |
| incidence of tumour lysis syndrome (grade >=3) | 7.4 % | AG120-C-001 · p.218 |
| incidence of grade 3 QT prolongation | 17 % | AG-221-AML-005 · p.223 |
| incidence of leukocytosis (any grade) | 1.4 % | AG120-C-009 · p.223 |
| incidence of leukocytosis (any grade) | 11.3 % | AG120-C-009 · p.223 |
Source: Servier ↗ · 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 →