ELAHERE
ELAHERE is an antibody-drug conjugate indicated for the treatment of adult patients with folate receptor-alpha (FRα) positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. This therapy is intended for patients who have previously received one to three systemic treatment regimens. Candidates for treatment must be selected using an FDA-approved test to confirm the presence of the FRα target.
How ELAHERE Works
Mirvetuximab soravtansine-gynx is an antibody-drug conjugate consisting of a chimeric IgG1 antibody directed against folate receptor alpha (FRα) and a microtubule inhibitor called DM4. After the antibody binds to FRα on the cell surface, the drug is internalized and DM4 is released intracellularly via proteolytic cleavage. The released DM4 disrupts the microtubule network within the cell, which leads to cell cycle arrest and apoptotic cell death.
Details
- Status
- Prescription
- First Approved
- 2022-11-14
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
ELAHERE Approval History
What ELAHERE Treats
3 indicationsELAHERE is approved for 3 conditions since its original approval in 2022. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Epithelial Ovarian Cancer
- Fallopian Tube Cancer
- Primary Peritoneal Cancer
ELAHERE Boxed Warning
OCULAR TOXICITY ELAHERE can cause severe ocular toxicities, including visual impairment, keratopathy, dry eye, photophobia, eye pain, and uveitis [see Warnings and Precautions ( 5.1 ) and Adverse Reactions ( 6.1 )] . Conduct an ophthalmic exam including visual acuity and slit lamp exam prior to initiation of ELAHERE, every other cycle for the first 8 cycles, and as clinically indicated [see Dosage and Administration ( 2.3 )] . Administer prophylactic artificial tears and ophthalmic topical stero...
WARNING: OCULAR TOXICITY ELAHERE can cause severe ocular toxicities, including visual impairment, keratopathy, dry eye, photophobia, eye pain, and uveitis [see Warnings and Precautions ( 5.1 ) and Adverse Reactions ( 6.1 )] . Conduct an ophthalmic exam including visual acuity and slit lamp exam prior to initiation of ELAHERE, every other cycle for the first 8 cycles, and as clinically indicated [see Dosage and Administration ( 2.3 )] . Administer prophylactic artificial tears and ophthalmic topical steroids [see Dosage and Administration ( 2.3 ) and Warnings and Precautions ( 5.1 )] . Withhold ELAHERE for ocular toxicities until improvement and resume at the same or reduced dose [see Dosage and Administration ( 2.4 ) and Warnings and Precautions ( 5.1 )] . Discontinue ELAHERE for Grade 4 ocular toxicities [see Dosage and Administration ( 2.4 ) and Warnings and Precautions ( 5.1 )] . WARNING: OCULAR TOXICITY See full prescribing information for complete boxed warning. ELAHERE can cause severe ocular toxicities, including visual impairment, keratopathy, dry eye, photophobia, eye pain, and uveitis. ( 5.1 , 6.1 ) Conduct an ophthalmic exam including visual acuity and slit lamp exam prior to initiation of ELAHERE, every other cycle for the first 8 cycles, and as clinically indicated. ( 2.3 ) Administer prophylactic artificial tears and ophthalmic topical steroids. ( 2.3 , 5.1 ) Withhold ELAHERE for ocular toxicities until improvement and resume at the same or reduced dose. ( 2.4 , 5.1 ) Discontinue ELAHERE for Grade 4 ocular toxicities. ( 2.4 , 5.1 )
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ELAHERE FDA Label Details
ProIndications & Usage
FDA Label (PDF)ELAHERE ® is 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. Select patients for therapy based on an FDA-approved test [see Dosage and Administration ]. ELAHERE 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 r...
WARNING: OCULAR TOXICITY ELAHERE can cause severe ocular toxicities, including visual impairment, keratopathy, dry eye, photophobia, eye pain, and uveitis [see Warnings and Precautions ( 5.1 ) and Adverse Reactions ( 6.1 )] . Conduct an ophthalmic exam including visual acuity and slit lamp exam prio...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.