AbbVie (NYSE: ABBV) shares lost ground Friday. The company announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the marketing authorization of mirvetuximab soravtansine (ELAHERE®) for the treatment of adult patients with folate receptor alpha (FRa)-positive, platinum-resistant and high-grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer who have received one to three prior treatment regimens.
Patients with ovarian cancer are often diagnosed with late-stage disease, undergo surgery and are then primarily treated with platinum-based chemotherapy. Over time patients may become resistant to platinum-based treatment and will require another therapy. The CHMP’s opinion is supported by results of the Phase 3 MIRASOL clinical trial and the European Commission decision on this indication for mirvetuximab soravtansine is anticipated later this year.
“Following many years of development by the ImmunoGen team that is now part of AbbVie, we are hopeful to make mirvetuximab soravtansine available to eligible patients with ovarian cancer in the European Union. This positive opinion recognizes the unmet need for certain patients with platinum-resistant ovarian cancer,” said Chief Scientific Officer Roopal Thakkar.
ELAHERE® (mirvetuximab soravtansine-gynx) was granted full FDA approval in the United States in March of this year. Marketing authorization submissions for mirvetuximab soravtansine are under review in multiple other countries.
ABBV shares dipped 96 cents to $192.66.