Pfizer Inc. — Besponsa EMA EPAR variation assessment report (EMEA/H/C/004119, 2017)
Pfizer Inc. · 2017 · EMA EPAR variation assessment report · company profile →
Report summary
This report summarizes the assessment of paediatric studies for Besponsa (inotuzumab ozogamicin) in relapsed/refractory CD22-positive B-cell precursor acute lymphoblastic leukaemia (ALL). It details efficacy results, including overall response rates, duration of response, event-free survival, and overall survival, which are consistent with previous findings. The report also covers safety findings such as treatment-emergent adverse events, serious adverse events, veno-occlusive disease rates, and non-relapse mortality. The safety profile in paediatric patients is deemed acceptable. The regulatory status of Besponsa for adult and paediatric indications in the EU and US is also mentioned.
Key findings — cited to the page
| Number of participants treated | 83 | Study ITCC-059 · p.9 |
| Approval date for adults with R/R BCP-ALL | 17 August 2017 | Besponsa · United States · p.6 |
| Approval date for adults with R/R BCP-ALL | 29 June 2017 | Besponsa · EU · p.6 |
| Approval date for adults with R/R BCP-ALL | 10 July 2017 | Besponsa · Switzerland · p.6 |
| Approval date for adults with R/R BCP-ALL | 19 January 2018 | Besponsa · Japan · p.6 |
| Cumulative incidence rate of non-relapse mortality at Month 24 | 8.50 % | ITCC-059 · p.19 |
| Cumulative incidence rate of non-relapse mortality at Month 24 | 21.43 % | ITCC-059 · p.19 |
| Cumulative incidence rate of non-relapse mortality at Month 24 | 13.68 % | ITCC-059 · p.19 |
| Number of participants treated in Stratum 1A | 25 | Study ITCC-059 · p.9 |
| Number of participants treated in Phase 2 Cohort | 28 | Study ITCC-059 · p.9 |
| Number of participants treated in Stratum 1B | 30 | Study ITCC-059 · p.9 |
| Number of participants assigned to treatment | 85 | Study ITCC-059 · p.9 |
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 →