Unknown MAH — Tepadina EMA EPAR public assessment report (EMEA/H/C/001046, 2010)
Unknown MAH · 2010 · EMA EPAR public assessment report
Report summary
The EMA granted marketing authorization for Tepadina (thiotepa) as an orphan medicinal product for conditioning prior to haematopoietic progenitor cell transplantation (HPCT) in adults and children. The application, based on 'well-established medicinal use' due to over 10 years of EU clinical use, was supported by extensive literature. Thiotepa's non-clinical profile details its anti-tumor activity, pharmacokinetics, and established genotoxic, carcinogenic, and reproductive toxicities. Clinical studies demonstrated Tepadina's efficacy and safety in combination with other chemotherapeutic agents for HPCT in various hematological diseases and solid tumors, showing acceptable overall survival, event-free survival, and engraftment rates. The safety profile, including adverse events, serious adverse events, and mortality rates, was generally acceptable across adult and pediatric populations, with common toxicities including myelosuppression, mucositis, and infections.
Key findings — cited to the page
| grade III-IV pulmonary toxicity | 6 % | · p.42 |
| acute GvHD grade III-IV (MUD recipients) | 36-61 % | · p.47 |
| Acute GvHD grade III/IV | 5 % | · p.45 |
| severe nonhaematological toxicity events (grade IV/V) | 14 | · p.46 |
| acute GvHD grade I-II | 5 | · p.47 |
| acute GvHD grade III-IV (sibling-matched recipients) | 10-30 % | · p.47 |
| patients with severe nonhaematological toxicity events (grade IV/V) | 18 % | · p.46 |
| GvHD grade III-IV | 3 | · p.47 |
| acute GvHD grade III-IV | 2 % | · p.39 |
| adverse event of grade III-IV at bladder level | 6.7 % | leukemia patients (N=15) received thiotepa in combination with melphalan, antilymphocyte globulin and TBI · p.51 |
| acute GvHD grade III-IV | 32 % | · p.39 |
| acute GvHD (grade I-II) | 22 % | unrelated donor BMT in adult, class 3 thalassemia patients · p.48 |
Source: Unknown MAH ↗ · 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 →