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Mirvetuximab soravtansine: Elahere

Marketing authorisation number 69700, date marketing authorisation granted: 13/03/2025

We publish synopses from Clinical Study Reports (CSR) to supplement the public information. This provides patients and healthcare providers with the results of our clinical trials and the evidence used for the authorisation of ELAHERE.

Here you can find the CSR synopses after ELAHERE was granted marketing authorisation in Switzerland.

IMGN853-0417 (SORAYA)

Study indication: platinum-resistant, advanced high-grade epithelial ovarian, primary peritoneal or fallopian tube cancer with high folate receptor alpha expression
Phase: phase 3
Study name: A single-arm phase 3 study of mirvetuximab soravtansine in platinum-resistant, advanced high-grade epithelial ovarian, primary peritoneal or fallopian tube cancer with high folate receptor alpha expression.
EudraCT number: 2020-000179-19


IMGN853-0416 (MIRASOL)

Study indication: platinum-resistant, advanced high-grade epithelial ovarian, primary peritoneal or fallopian tube cancer with high folate receptor alpha expression
Phase: phase 3
Study name: A randomised, open-label phase III study of mirvetuximab soravtansine versus investigator-selected chemotherapy in platinum-resistant, advanced high-grade epithelial ovarian, primary peritoneal or fallopian tube cancer with high folate receptor alpha expression.
EudraCT number: 2019-003509-80