The FDA recently approved a new infused therapy, Elahere (mirvetuximab soravtansine-gynx) from ImmunoGen Inc., indicated for the treatment of adult patients with folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens.
Elahere is a first-in-class antibody-drug conjugate (ADC) directed against FRα, a cell-surface protein highly expressed in ovarian cancer and is the first FDA approved ADC for platinum-resistant disease.
Elahere can cause severe ocular toxicity and its accelerated approval is contingent upon verification and description of clinical benefit in a confirmatory trial.
Elahere dosage is body weight and is administered every 3 weeks until disease progression or unacceptable toxicity. ImmunoGen priced Elahere at $6,220 per 20 mg dose. Dosing is three – four vials per treatment cycle resulting in a cost of +- $18,500 — $25,000.
ImmunoGen did not disclose details related to distribution. The company did confirm that the target US patient base is only 5200. Given this small patient opportunity it is likely that Elahere will be launched through specialty pharmacy distribution.
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