Tepadina

Oncology· 409 cited findings· 1 source document

Company: Unknown MAH

What the regulatory reviews say

Tepadina is a drug for which an Orphan Medicinal Product designation was granted on 29 January 2007, due to a prevalence of the condition of 0.5 per 10,000 EU population. The Marketing Authorisation application was submitted on 4 July 2008, and a CHMP positive opinion was issued on 17 December 2009. Thiotepa, the active substance, has an IARC classification of Group 1 and has 10 years of well-established use in the EU.

Efficacy findings include a 5-year estimated overall survival (OS) of 68.8% and a 5-year estimated event-free survival (EFS) of 61.5%. The relapse mortality was 8.7%, and the overall relapse rate was 13%. The estimated relapse at 3 years was 32%. The response rate observed was 33%, with a partial remission rate of 50%. In a specific group, 21 patients were alive, and 6 patients were in complete remission (CR) following TT/BU/MEL+TMI treatment.

Safety data includes patient exposure of 6588 patients, with 316 patients included in the safety analysis for autologous hematopoietic progenitor cell transplantation (HPCT). Transplant-related mortality (TRM) was reported at 1% and 16% in different contexts. Grade III-IV pulmonary toxicity occurred in 6% of patients, and second malignancies (late toxicity) were observed in 5% of patients. Renal replacement therapy (RRT) was required in 9.7% of patients.

Key figures — cited to the source page

5-year estimated OS	68.8	Unknown MAH — Tepadina EMA EPAR public assessment report (EM, p.33
5-year estimated EFS	61.5	Unknown MAH — Tepadina EMA EPAR public assessment report (EM, p.33
Relapse mortality	8.7	Unknown MAH — Tepadina EMA EPAR public assessment report (EM, p.43
TRM	1	Unknown MAH — Tepadina EMA EPAR public assessment report (EM, p.42
Grade III-IV pulmonary toxicity	6	Unknown MAH — Tepadina EMA EPAR public assessment report (EM, p.42
Second malignancies (late toxicity)	5	Unknown MAH — Tepadina EMA EPAR public assessment report (EM, p.42
Orphan medicinal product designation date	29 January 2007	Unknown MAH — Tepadina EMA EPAR public assessment report (EM, p.3
CHMP positive opinion date	17 December 2009	Unknown MAH — Tepadina EMA EPAR public assessment report (EM, p.4

Source documents

Unknown MAH — Tepadina EMA EPAR public assessment report (EMEA/H/C/001046, 2010) (2010)

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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.