Lysodren

Oncology· 52 cited findings· 1 source document

Company: Esteve S A

What the regulatory reviews say

Lysodren is a drug for which a Phase III trial was conducted with an actual enrollment of 304 patients. The drug received orphan medicinal product designation on 12 June 2002.

Efficacy findings from the trial include a median progression-free survival of 5.0 months, with a PFS Hazard Ratio of 0.55 (95% CI: 0.43 to 0.69, p-value: <0.001). The median overall survival was 14.8 months, with an OS Hazard Ratio of 0.79 (95% CI: 0.61 to 1.02, p-value: 0.07). The Objective Response Rate (ORR) was 20.7%, and the Disease Control Rate (DCR) was 62.9%. Safety data indicated that 39 patients experienced at least one adverse event. Four patients died in the high-dose regimen, and 4 patients in the high-dose regimen experienced treatment-related serious adverse events. A mitotane plasma level of 20 mg/l was associated with neurologic toxicity and severe undesirable effects.

Key figures — cited to the source page

Median progression-free survival	5.0 months	Esteve S A — Lysodren EMA EPAR variation assessment report, p.9
PFS Hazard Ratio	0.55	Esteve S A — Lysodren EMA EPAR variation assessment report, p.9
Median overall survival	14.8 months	Esteve S A — Lysodren EMA EPAR variation assessment report, p.9
Objective Response Rate (ORR)	20.7 %	Esteve S A — Lysodren EMA EPAR variation assessment report, p.14
Patients with at least one AE	39 patients	Esteve S A — Lysodren EMA EPAR variation assessment report, p.17
Deaths in high dose regimen	4 patients	Esteve S A — Lysodren EMA EPAR variation assessment report, p.17
Mitotane plasma level associated with neurologic toxicity	20 mg/l	Esteve S A — Lysodren EMA EPAR variation assessment report, p.22
Orphan medicinal product designation date	12 June 2002	Esteve S A — Lysodren EMA EPAR variation assessment report, p.2

Source documents

Esteve S A — Lysodren EMA EPAR variation assessment report (EMEA/H/C/000521, 2004) (2004)

Explore the full evidence

All 52 cited findings for Lysodren — searchable, comparable and answerable in plain language — are in the Oncology research library →

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.