Orserdu(elacestrant)
OncologyΒ· 1039 cited findingsΒ· 1 source document
Company: Stemline B V
What the regulatory reviews say
Orserdu (elacestrant) is a medication indicated for the treatment of breast cancer. Regulatory review documents report a median overall survival of 24.61 months for elacestrant and 22.57 months for the comparator arm in a study, with an overall survival hazard ratio (95% CI) of 0.912 (0.708-1.175). In ESR1-mut subjects, the median overall survival in the standard of care (SOC) group was 16.95 months, with an OS p-value of 0.0325. The binding affinity of elacestrant for ERΞ± (IC50) is 48 nM.
Notable safety findings include hERG channel current inhibition at 0.41 Β΅M (IC50) and 86.8%. Cardiovascular effects observed include a PR interval decrease of 6% to 11%, a QRS duration increase of 10%, a diastolic pressure increase of 11%, a systolic pressure increase of 6%, a mean arterial pressure increase of 8%, and heart rate increases of 10%, 14%, and 22%. The recommended daily dose of Orserdu is 345 mg.
The marketing authorization application for Orserdu was submitted on 27 July 2022, with a CHMP positive opinion date of 20 July 2023. A post-approval study report submission is planned for June 2026, and the final report for a clinical PK study in non-cancer patients is also expected in June 2026.
Key figures β cited to the source page
| OS p-value (ESR1-mut subjects) | 0.0325 | Stemline B V β Orserdu EMA EPAR public assessment report (EM, p.119 |
| Median OS in SOC group (ESR1-mut subjects) | 16.95 months | Stemline B V β Orserdu EMA EPAR public assessment report (EM, p.121 |
| median overall survival (months) | 24.61 months | Stemline B V β Orserdu EMA EPAR public assessment report (EM, p.122 |
| overall survival HR (95% CI) | 0.912 (0.708-1.175) | Stemline B V β Orserdu EMA EPAR public assessment report (EM, p.122 |
| binding affinity of elacestrant for ERΞ± (IC50) | 48 nM | Stemline B V β Orserdu EMA EPAR public assessment report (EM, p.23 |
| IC50 for hERG channel current inhibition | 0.41 Β΅M | Stemline B V β Orserdu EMA EPAR public assessment report (EM, p.34 |
| Recommended daily dose of ORSERDU | 345 mg | Stemline B V β Orserdu EMA EPAR public assessment report (EM, p.13 |
| CHMP positive opinion date | 20 July 2023 | Stemline B V β Orserdu EMA EPAR public assessment report (EM, p.9 |
Source documents
Explore the full evidence
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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials β values are not head-to-head comparisons). Educational reference only β not medical or investment advice.