IMGN - ImmunoGen wins FDA approval of antibody-drug conjugate Elahere for ovarian cancer
- The US FDA has granted accelerated approval to ImmunoGen ( NASDAQ: IMGN ) for Elahere (mirvetuximab soravtansine) , an antibody-drug conjugate ("ADC") for platinum-resistant ovarian cancer.
- Shares are up 9% in after-hours trading.
- The approval is specifically for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer in those who have received one to three prior regimens.
- ImmunoGen ( IMGN ) noted that Elahere is a first-in-class ADC directed against FR?, a cell-surface protein highly expressed in ovarian cancer. It is also the first FDA-approved ADC for a platinum-resistant disease.
- Approval was based on results from a single-arm trial of 106 patients that showed an overall response rate of 31.7% and median duration of response of 6.9 months.
- See why Seeking Alpha contributor Avisol Capital Partners considers ImmunoGen ( IMGN ) a hold.
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ImmunoGen wins FDA approval of antibody-drug conjugate Elahere for ovarian cancer