Pfizer Inc. — Besponsa EMA EPAR public assessment report (EMEA/H/C/004119, 2017)
Pfizer Inc. · 2017 · EMA EPAR public assessment report · company profile →
Report summary
This EMA EPAR summarizes the regulatory approval of Besponsa (inotuzumab ozogamicin) for relapsed/refractory B-cell precursor acute lymphoblastic leukaemia. The report details the manufacturing process, quality control, and non-clinical safety, including toxicokinetic and toxicity profiles in animals. Clinical trials (Phase 1, 2, and 3) demonstrated Besponsa's superior efficacy over chemotherapy in achieving remission and MRD negativity, with improved overall survival. However, safety concerns, particularly veno-occlusive disease/sinusoidal obstruction syndrome (VOD/SOS) and other adverse events, were noted. Despite these, the CHMP concluded a positive benefit-risk balance, recommending marketing authorization.
Key findings — cited to the page
| Thrombocytopenia Incidence of Grade ≥3 | 40.9 % | · p.129 |
| Hepatotoxicity Incidence of Grade ≥3 | 29.3 % | · p.129 |
| Grade 5 SAEs Incidence for control | 11.2 % | · p.129 |
| Neutropenia Incidence of Grade ≥3 for control | 44.1 % | · p.129 |
| Febrile neutropenia Incidence of Grade ≥3 | 26.8 % | · p.129 |
| Febrile neutropenia Incidence of Grade ≥3 for control | 53.8 % | · p.129 |
| Grade 3 increased ALT at 1.6 mg/m2 dose level | 1 event | · p.58 |
| Grade 5 SAEs Incidence | 15.9 % | · p.129 |
| Grade 3 increased ALT at 1.8 mg/m2 dose level | 1 event | · p.58 |
| Neutropenia Incidence of Grade ≥3 | 47.0 % | · p.129 |
| Thrombocytopenia Incidence of Grade ≥3 for control | 59.4 % | · p.129 |
| Hepatotoxicity Incidence of Grade ≥3 for control | 14.7 % | · p.129 |
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 →