IMGN - ImmunoGen's ovarian cancer medication accepted for EU review

2023-10-27 07:38:20 ET

The European Medicines Agency (EMA) has accepted marketing authorization application for ImmunoGen's ( NASDAQ: IMGN ) cancer medication.

The agency accepted ImmunoGen's ( IMGN ) marketing authorization application for ELAHERE (mirvetuximab soravtansine-gynx), which is indicated for the treatment of adult patients with folate receptor-alpha (FR?) positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens.

The medication received approval from the U.S. Food and Drug Administration in November 2022.

The latest authorization is supported by positive data from the Phase 3 MIRASOL trial of ELAHERE in platinum-resistant ovarian cancer, where it showed statistically significant and clinically meaningful improvements in progression-free survival, objective response rate, and overall survival compared to investigator's choice of single-agent chemotherapy.

The company hopes to bring this novel treatment to Europe as early as 2024.

Shares of ImmunoGen ( IMGN ) were up over 1% premarket on Friday

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