FDA grants full approval to AbbVie’s ovarian cancer drug
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NORTH CHICAGO, Ill. – AbbVie (NYSE: NYSE:ABBV) has received full approval from the U.S. Food and Drug Administration (FDA) for ELAHERE® (mirvetuximab soravtansine-gynx) as a treatment for a specific type of ovarian cancer. This marks a significant milestone for the pharmaceutical company, particularly after its recent acquisition of ImmunoGen (NASDAQ:IMGN), which developed the drug.
ELAHERE is now approved for adult patients with folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. These patients typically have undergone surgery and multiple therapies, including platinum-based chemotherapy, and may develop resistance requiring alternative treatments.
The approval is supported by results from the Phase 3 MIRASOL trial, which demonstrated a 35% reduction in the risk of cancer progression and a 33% reduction in the risk of death when compared to the control group receiving the investigator’s choice of chemotherapy.
The trial, which enrolled 453 patients, used progression-free survival (PFS) as its primary endpoint and also evaluated overall survival (OS) and objective response rate (ORR) as key secondary endpoints.
According to Roopal Thakkar, M.D., AbbVie’s senior vice president and chief medical officer, “The full FDA approval of ELAHERE for eligible patients with ovarian cancer represents the culmination of years of work by the ImmunoGen team.”
Kathleen Moore, deputy director at the Stephenson Cancer Center of The University of Oklahoma and MIRASOL principal investigator, added that ELAHERE is the first treatment to show a statistically significant overall survival benefit in patients with platinum-resistant ovarian cancer.
ELAHERE is an antibody-drug conjugate that includes a folate receptor alpha-binding antibody, a cleavable linker, and the maytansinoid payload DM4, which is designed to target and kill cancer cells.
The drug’s safety profile showed fewer Grade 3+ adverse events and lower discontinuation rates due to adverse events compared to the control group. However, severe ocular toxicities, including visual impairment and keratopathy, were noted as potential risks.
The Marketing Authorization Application for ELAHERE is also under review in Europe by the European Medicines Agency (EMA) and in multiple other countries. This approval could be a step forward for AbbVie’s oncology portfolio, as the company continues to explore new cancer treatments.
The information about ELAHERE’s approval and its clinical trial results is based on a press release statement from AbbVie.
