AbbVie’s ELAHERE Receives EU Approval for Treating Platinum-Resistant Ovarian Cancer

CAR-T Digest - August 2020

18 Nov 2024: AbbVie’s ELAHERE Receives EU Approval for Treating Platinum-Resistant Ovarian Cancer

AbbVie received European Commission marketing authorization for ELAHERE (Mirvetuximab soravtansine), the first folate receptor alpha-directed ADC approved in the EU and surrounding regions
ELAHERE is indicated for adults with platinum-resistant, FRα-positive high-grade serous ovarian, fallopian tube, or primary peritoneal cancer after one to three prior treatments
This approval is the first new treatment for platinum-resistant ovarian cancer in the EU in a decade, addressing a significant need due to high mortality rates
The MIRASOL Phase 3 trial demonstrated ELAHERE’s efficacy, showing a 35% reduction in tumor progression or death and a 33% reduction in overall mortality compared to standard chemotherapy
Roche’s VENTANA FOLR1 RxDx Assay, now CE marked, will help identify eligible patients by detecting the FRα biomarker, found in about one-third of ovarian cancer cases