ELAHERE

What it is

ELAHERE is mirvetuximab soravtansine, a concentrate solution for intravenous infusion supplied as a single-dose vial containing 100 mg in 20 mL (5 mg/mL). Mirvetuximab soravtansine is a folate receptor alpha (FRα)-directed antibody-drug conjugate (ADC) consisting of an anti-FRα monoclonal antibody of human immunoglobulin G (IgG) 1 subtype, the small molecule anti-tubulin agent DM4 (a maytansine derivative), and a linker that covalently attaches DM4 to the antibody. An average of 3.4 molecules of DM4 are attached to each antibody molecule.

Approved indications

— Adult patients with folate receptor-alpha (FRα) positive, platinum-resistant high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens.

Dosing overview

The recommended dose of ELAHERE is 6 mg/kg adjusted ideal body weight (AIBW) administered once every 3 weeks (21-day cycle) as an intravenous infusion until disease progression or unacceptable toxicity. Dosing based on AIBW reduces exposure variability for patients who are either underweight or overweight. Premedication prior to each ELAHERE infusion includes intravenous dexamethasone 10 mg at least 30 minutes prior, oral or intravenous diphenhydramine 25 mg to 50 mg, oral or intravenous paracetamol 325 mg to 650 mg, and oral or intravenous 5-HT3 serotonin receptor antagonist or appropriate alternatives. The initial dose should be administered as an intravenous infusion at the rate of 1 mg/min, which can be increased to 3 mg/min if well tolerated after 30 minutes, and then to 5 mg/min if well tolerated after a further 30 minutes.

Key safety warnings

ELAHERE can cause severe ocular adverse reactions, including visual impairment (predominantly blurred vision), keratopathy (corneal disorders), dry eye, photophobia, and eye pain. Patients should be referred to an eye care professional for an ophthalmic exam before initiation of ELAHERE. An ophthalmic exam including visual acuity and slit lamp exam should be conducted prior to initiation of ELAHERE, and thereafter if a patient develops new or worsening ocular symptoms prior to the next dose; in patients with Grade ≥2 ocular adverse reactions, additional ophthalmic exams should be conducted at a minimum of every other cycle until resolution or return to baseline. Severe, life-threatening, or fatal interstitial lung disease (ILD), including pneumonitis, can occur in patients treated with ELAHERE. Patients should be monitored for pulmonary signs and symptoms of pneumonitis, which may include hypoxia, cough, dyspnoea, or interstitial infiltrates on radiologic exams, with infectious, neoplastic, and other causes excluded through appropriate investigations. Peripheral neuropathy has occurred with ELAHERE treatment, including Grade ≥3 reactions, and patients should be monitored for signs and symptoms such as paraesthesia, tingling or a burning sensation, neuropathic pain, muscle weakness, or dysesthesia. Mirvetuximab soravtansine could cause embryofetal harm when administered to a pregnant patient because it contains a genotoxic compound (DM4) and affects actively dividing cells; patients of childbearing potential should use effective contraception during treatment with mirvetuximab soravtansine and for 7 months after the last dose.

Contraindications

Hypersensitivity to the active substance or any of the excipients listed in the product information.

PBS listing

No PBS listing information is available in the provided documents.

Regulatory history

ELAHERE (mirvetuximab soravtansine 100 mg/20 mL concentrate solution for intravenous infusion vial) was first registered on the ARTG on 19 February 2026. The PBAC deferred consideration in July 2025 for high grade epithelial ovarian, fallopian tube or primary peritoneal cancer with platinum-resistant disease and high folate receptor alpha (FRα) expression, pending TGA assessment and MSAC consideration of FRα expression testing.