FDA Grants Full Approval to Elahere

The FDA has granted full approval for Elahere (mirvetuximab soravtansine-gynx) to treat adult patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer. It is indicated for women who have received one to three prior systemic treatment regimens.

Elahere had been granted accelerated approval in November 2022. It is an antibody-drug conjugate targeted against folate receptor alpha, a cell-surface protein highly expressed in ovarian cancer. About 35% to 40% of ovarian cancer patients express high levels of folate receptor alpha.

Elahere was developed by ImmunoGen, which AbbVie acquired in February 2024. When Elahere launched, the wholesale acquisition cost was $6,220 for one vial, and patients, typically undergo the use of three to four vials per cycle. This translates to $18,660 to $24,800 per treatment cycle.

Related: FDA Grants Accelerated Approval of Novel Ovarian Cancer Therapy

The full approval is based on data from the confirmatory phase 3 MIRASOL trial, which showed that Elahere resulted in a 33% reduction in risk of death and a 35% reduction in the risk of cancer progression

The trial enrolled 453 patients and compared Elahere with investigator’s choice (IC) of chemotherapy. The primary end point was progression-free survival (PFS) by investigator assessment and key secondary endpoints included objective response rate (ORR) and overall survival (OS).

The label includes a boxed warning about ocular toxicity, including visual impairment, keratopathy (corneal disorders), dry eye, photophobia, eye pain, and uveitis (inflammation). The label also requires patients to have an ophthalmic exam every other cycle for the first eight cycles.

Other warnings includes the risk of severe, life-threatening interstitial lung disease, including pneumonitis, as well as peripheral neuropathy.