Pfizer Inc. — Sutent EMA EPAR variation assessment report (EMEA/H/C/000687, 2006)
Pfizer Inc. · 2006 · EMA EPAR variation assessment report · company profile →
Report summary
This report summarizes a Type II variation application for Sutent (sunitinib) to update its SmPC with pediatric study results. The aim is to provide information on dosing, administration, adverse reactions, pharmacokinetics, and clinical activity in pediatric cancer patients, including those with GIST. While a pediatric indication is not sought due to an unfavorable benefit/risk profile, the variation was recommended for approval to include the available data. Studies A6181196, ACNS1021, and ADVL0612 showed no confirmed objective responses in pediatric GIST, with high incidences of Grade 3/4 adverse events and dose-limiting toxicities. PK analyses suggest a pediatric dose of approximately 20 mg/m2/day to achieve comparable exposure to adults, despite significant toxicities observed.
Key findings — cited to the page
| Sunitinib MTD (pediatric, no prior anthracyclines/cardiac irradiation) | 15 mg/m2/day | ADVL0612 · p.5 |
| Patients with Grade 3 or 4 AEs | 6 % | Study ADVL0612, Sunitinib Part C · p.78 |
| Grade 3-4 treatment-related adverse events | 66.7 % | Phase 1/2 study of oral sunitinib · p.108 |
| Grade 4 hypocalcaemia | 2 | study ACNS1021 · p.103 |
| Grade 3 hypokalemia | 1 | study ACNS1021 · p.103 |
| Grade 3-4 treatment-related adverse events | 4/6 patients | Phase 1/2 study of oral sunitinib · p.108 |
| Patients with Grade 3 or 4 AEs | 5 % | Study ADVL0612, Sunitinib Part B · p.78 |
| Grade 3 hypophosphatemia, neutropenia, and thrombocytopenia | 1 patient each | Phase 1/2 study of oral sunitinib · p.108 |
| Grade 4 neutropenia | 1 patient | Phase 1/2 study of oral sunitinib · p.108 |
| Grade 3 adverse drug reactions (fatigue, gastrointestinal adverse drug reactions, haematologic adverse drug reactions) | 2 patients each | · p.108 |
| Grade 3 adverse drug reactions (cholecystitis, hyperthyroidism, mucositis) | 1 patient each | · p.108 |
| Patients with Grade 5 AEs | 1 % | Study ADVL0612, Sunitinib Part B · p.78 |
Source: Pfizer 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 →