FDA grants full approval for Elahere (mirvetuximab soravtansine-gynx) for certain ovarian cancer patients – Abbvie

AbbVie announced that the FDA has granted full approval for Elahere (mirvetuximab soravtansine-gynx) for the treatment of folate receptor alpha (FR?)-positive, platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal adult cancer patients treated with up to three prior therapies. Patients with these cancers often present with late-stage disease, undergo surgery and are then treated with platinum-based chemotherapy. They may become resistant to this treatment and require another therapy, such as Elahere.

“The full FDA approval of Elahere for eligible patients with ovarian cancer represents the culmination of years of work by the ImmunoGen team. Elahee is the first and only antibody-drug conjugate (ADC) approved in the U.S. for this difficult-to-treat malignancy,” said Roopal Thakkar, M.D., senior vice president, chief medical officer, global therapeutics, AbbVie.

Elahere was first granted FDA accelerated approval in November 2022 and the conversion to full approval is based on data from the confirmatory Phase III MIRASOL trial. This trial compared Elahere to investigator’s choice (IC) of chemotherapy in patients with platinum-resistant ovarian cancer (PROC) whose tumors express high levels of FR? and who have been treated with up to three prior therapies. The primary endpoint of MIRASOL was progression-free survival (PFS) by investigator assessment and key secondary endpoints included objective response rate (ORR) and overall survival (OS).

As the first treatment to show a statistically significant overall survival benefit in patients with platinum-resistant ovarian cancer, Elahere provides an effective new option for patients with folate receptor alpha positive tumors. These patients previously had very limited options and Elahere changes that,” said Kathleen Moore, deputy director and associate director of clinical research at the Stephenson Cancer Center of The University of Oklahoma and MIRASOL principal investigator.