AbbVie Inc. — Venclyxto EMA EPAR public assessment report (EMEA/H/C/004106, 2016)
AbbVie Inc. · 2016 · EMA EPAR public assessment report · company profile →
Report summary
The European Medicines Agency (EMA) granted marketing authorization for AbbVie's Venclyxto (venetoclax) in October 2016, following its orphan medicinal product designation for chronic lymphocytic leukaemia (CLL). The authorization targets adult CLL patients with 17p deletion or TP53 mutations, or those who have failed prior therapies. Non-clinical studies revealed potential testicular and embryo-foetal toxicity, addressed in the Risk Management Plan. Clinical pharmacology characterized venetoclax's pharmacokinetics, including CYP3A4 metabolism. Efficacy data from CLL/SLL patients demonstrated high response rates, with 400 mg QD identified as the optimal dose. Safety analysis highlighted common adverse events like neutropenia, infections, and tumor lysis syndrome, along with gastrointestinal, cardiac, bleeding, and hepatobiliary issues, and their management.
Key findings — cited to the page
| Grade 3 or 4 Febrile neutropenia (All Subjects) | 5.7 % | All 400 mg Analysis Set · p.88 |
| Grade 3 or 4 Pneumonia (All Subjects) | 5.1 % | All 400 mg Analysis Set · p.88 |
| Grade 3 or 4 TEAE (All Subjects) | 76.0 % | All 400 mg Analysis Set · p.86 |
| Grade 3 or 4 Autoimmune haemolytic anaemia (All Subjects) | 4.4 % | All 400 mg Analysis Set · p.88 |
| Grade 3 or 4 Neutropenia (All Subjects) | 37.2 % | All 400 mg Analysis Set · p.88 |
| Grade 3 or 4 Thrombocytopenia (All Subjects) | 13.5 % | All 400 mg Analysis Set · p.88 |
| Nausea (all grades) in CLL/SLL subjects | 47.4 % | Study M12-175 · p.59 |
| Neutropenia (all grades) in CLL/SLL subjects | 44.8 % | Study M12-175 · p.59 |
| Grade 3 or 4 TEAE (All Subjects) | 76.0 % | All 400 mg Analysis Set · p.88 |
| Grade 3 or 4 Anaemia (All Subjects) | 15.2 % | All 400 mg Analysis Set · p.88 |
| Diarrhoea (all grades) in CLL/SLL subjects | 49.1 % | Study M12-175 · p.59 |
| Grade 3 or 4 Neutrophil count decreased (All Subjects) | 8.8 % | All 400 mg Analysis Set · p.89 |
Source: AbbVie Inc. ↗ · 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 →