Elahere FDA Approval History
Last updated by Judith Stewart, BPharm on March 26, 2024.
FDA Approved: Yes (First approved November 14, 2022)
Brand name: Elahere
Generic name: mirvetuximab soravtansine-gynx
Previous name: mirvetuximab soravtansine
Dosage form: Injection
Company: ImmunoGen, Inc.
Treatment for: Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer
Elahere (mirvetuximab soravtansine-gynx) is a folate receptor alpha (FRα)-directed antibody and microtubule inhibitor conjugate indicated for the treatment of adult patients with FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens.
- Most patients with ovarian cancer will undergo surgery followed by platinum-based chemotherapy, however the majority of patients eventually develop platinum-resistant disease, which is difficult to treat.
- Elahere is a first-in-class antibody-drug conjugate directed against FRα, a cell-surface protein highly expressed in ovarian cancer. The antibody is a chimeric IgG1 directed against FRα. The small molecule, DM4, is a microtubule inhibitor designed to kill the targeted cancer cells. It is attached to the antibody via a cleavable linker.
- The VENTANA FOLR1 (FOLR1-2.1) RxDx Assay is a companion diagnostic to aid in identifying patients eligible for treatment with Elahere. Approximately 35-40% of ovarian cancer patients express high levels of FRα, and newly diagnosed patients can test at diagnosis to determine if Elahere will be an option for them at the time of progression to platinum resistance.
- The prescribing information for Elahere includes a boxed warning for ocular toxicity, including visual impairment, keratopathy, dry eye, photophobia, eye pain, and uveitis. Warnings and precautions associated with Elahere include pneumonitis, peripheral neuropathy, and embryo-fetal toxicity.
- Common adverse reactions include fatigue, blurred vision, nausea, diarrhea, abdominal pain, keratopathy, peripheral neuropathy, musculoskeletal pain, dry eye, constipation, vomiting, and decreased appetite.
Common laboratory abnormalities include increased aspartate aminotransferase, increased alanine aminotransferase, increased alkaline phosphatase, decreased lymphocytes, decreased platelets, decreased magnesium, decreased hemoglobin, decreased leukocytes, decreased albumin, and decreased neutrophils.
Development timeline for Elahere
Further information
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