ELAHERE: Uses, Dosage & Side Effects
An antibody-drug conjugate (ADC) targeting folate receptor alpha (FRα) for the treatment of platinum-resistant ovarian cancer, fallopian tube cancer, and primary peritoneal cancer
ELAHERE (mirvetuximab soravtansine-gynx) is an antibody-drug conjugate (ADC) used for the treatment of adult patients with folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. It is designed to selectively deliver a potent cytotoxic agent (DM4) to cancer cells that express folate receptor alpha on their surface. ELAHERE represents a significant advance in the treatment of platinum-resistant ovarian cancer, a disease that historically has had limited effective treatment options. It is administered as an intravenous infusion every three weeks and requires a prescription.
Quick Facts: ELAHERE
Key Takeaways
- ELAHERE (mirvetuximab soravtansine-gynx) is the first antibody-drug conjugate approved specifically for folate receptor alpha (FRα)-positive, platinum-resistant ovarian cancer, offering a targeted treatment option for a disease with historically limited choices.
- Tumor testing for FRα expression using an FDA-approved companion diagnostic is required before starting treatment to confirm eligibility for ELAHERE therapy.
- Ocular (eye) toxicity is the most characteristic side effect, affecting approximately 40–50% of patients; mandatory ophthalmic examinations and lubricating eye drops are required throughout the treatment course.
- ELAHERE is given as an intravenous infusion at a dose of 6 mg/kg adjusted ideal body weight once every three weeks, with the first infusion over approximately 60 minutes and subsequent infusions potentially shortened to 30 minutes if well tolerated.
- Women of reproductive potential must use effective contraception during treatment and for at least 7 months after the last dose, as ELAHERE can cause fetal harm based on its mechanism of action.
What Is ELAHERE and What Is It Used For?
ELAHERE contains the active substance mirvetuximab soravtansine-gynx, a novel type of anticancer medication known as an antibody-drug conjugate (ADC). ADC technology represents one of the most significant advances in targeted cancer therapy over the past decade, combining the exquisite specificity of a monoclonal antibody with the potent cell-killing ability of a cytotoxic drug. In the case of ELAHERE, the monoclonal antibody component is a humanized immunoglobulin G1 (IgG1) antibody engineered to recognize and bind with high affinity to folate receptor alpha (FRα), a protein that is highly expressed on the surface of many epithelial ovarian cancer cells but has limited expression on normal tissues.
Once the antibody component of ELAHERE binds to FRα on the tumor cell surface, the entire ADC complex is internalized into the cell through a process called receptor-mediated endocytosis. Inside the cell, the ADC is trafficked to lysosomes where the cleavable disulfide linker connecting the antibody to its cytotoxic payload is broken down. This releases the maytansinoid DM4, a potent tubulin-binding agent derived from the naturally occurring compound maytansine. DM4 inhibits tubulin polymerization and disrupts microtubule assembly, which are essential processes for cell division. By interfering with the microtubule network, DM4 induces cell cycle arrest and triggers apoptotic cell death. Because the drug is delivered preferentially to FRα-expressing cancer cells, ELAHERE achieves a high concentration of the cytotoxic agent at the tumor site while reducing systemic toxicity compared with conventional chemotherapy.
Folate receptor alpha is a glycosylphosphatidylinositol (GPI)-anchored membrane protein that mediates the cellular uptake of folate (a B vitamin essential for DNA synthesis and cell division). While FRα expression in normal tissues is largely restricted to the apical surface of certain epithelial cells (particularly in the kidneys, lungs, and choroid plexus), where it is relatively inaccessible to circulating antibodies, FRα is overexpressed on the surface of approximately 80% of epithelial ovarian cancers. This differential expression between tumor and normal tissues makes FRα an exceptionally attractive therapeutic target. Before starting treatment with ELAHERE, tumors must be tested for FRα expression using an FDA-approved companion diagnostic test (the VENTANA FOLR1 RxDx Assay) to confirm that the cancer is FRα-positive and therefore likely to respond to the therapy.
ELAHERE was initially granted accelerated approval by the U.S. Food and Drug Administration (FDA) in November 2022, based on impressive overall response rate data from the pivotal SORAYA trial. This approval was subsequently converted to full (traditional) approval in March 2024 based on confirmed clinical benefit demonstrated in the randomized, controlled MIRASOL trial. The European Medicines Agency (EMA) has also approved ELAHERE. ELAHERE is specifically approved for the following indication:
- FRα-positive, platinum-resistant epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer: ELAHERE is indicated for adult patients who have received one to three prior systemic treatment regimens. Platinum resistance is defined as disease progression during or within 6 months of the last platinum-containing regimen. The landmark MIRASOL trial (a randomized, open-label, phase III study) demonstrated that ELAHERE significantly improved progression-free survival (PFS) and overall survival (OS) compared with investigator’s choice chemotherapy (paclitaxel, pegylated liposomal doxorubicin, or topotecan).
Epithelial ovarian cancer is the most lethal gynecological malignancy and the fifth leading cause of cancer death among women worldwide. Despite initial responses to platinum-based chemotherapy, the majority of patients with advanced-stage disease ultimately develop platinum resistance, at which point treatment options become significantly limited. Historically, response rates to standard chemotherapy in the platinum-resistant setting have been modest, typically ranging from 10% to 15%. ELAHERE has changed this landscape by demonstrating overall response rates of approximately 42% in the SORAYA trial and significantly improved overall survival in the MIRASOL trial, providing a meaningful new treatment option for patients who previously had few effective therapies available.
Before starting ELAHERE, your tumor must be tested for folate receptor alpha (FRα) expression using the VENTANA FOLR1 (RxDx) Assay, an FDA-approved companion diagnostic. This immunohistochemistry (IHC) test is performed on tumor tissue from a biopsy or surgical specimen. Only patients whose tumors are confirmed to be FRα-positive (defined as ≥75% of viable tumor cells with membrane staining at ≥2+ intensity) are eligible for ELAHERE treatment. Your oncologist will arrange this testing as part of the treatment planning process.
What Should You Know Before Receiving ELAHERE?
Before starting treatment with ELAHERE, your healthcare team will conduct a thorough evaluation to ensure the medication is appropriate for you. This evaluation includes confirming FRα-positive tumor status, performing a comprehensive medical history review, conducting baseline laboratory tests, and completing an ophthalmic (eye) examination. Understanding the potential risks and required monitoring is essential for safe and effective treatment.
Contraindications
ELAHERE should not be used if you have a known severe hypersensitivity to mirvetuximab soravtansine-gynx or any of the excipients in the formulation. If you have experienced a serious allergic reaction to a previous dose of ELAHERE, you should not receive further treatment with this medication. There are no other absolute contraindications listed in the prescribing information; however, several conditions require careful consideration and close monitoring.
Warnings and Precautions
Ocular toxicity is the most important and characteristic adverse effect of ELAHERE. The cytotoxic payload DM4 can affect the corneal epithelium, leading to a range of eye problems including blurred vision, keratopathy (corneal changes visible on examination), dry eye, photophobia (light sensitivity), eye pain, tearing, and decreased visual acuity. In clinical trials, ocular adverse events occurred in approximately 43% of patients, with severe (Grade 3 or higher) events in about 8%. Ophthalmic examinations are mandatory before the first dose, before each subsequent dose, and as clinically indicated throughout treatment. Patients should use preservative-free lubricating eye drops at least 4 times daily starting from the day before each infusion and continuing for at least 72 hours after each dose. Contact lenses should not be worn during treatment. If significant ocular toxicity develops, dose modifications (delay, reduction, or permanent discontinuation) may be required.
Peripheral neuropathy may occur during treatment with ELAHERE, as the DM4 payload interferes with microtubule function. Peripheral neuropathy manifested as numbness, tingling, burning, pain, or weakness in the hands or feet has been reported. Patients should be monitored for signs and symptoms of neuropathy, and dose modifications may be necessary if neuropathy becomes significant. Patients with pre-existing neuropathy should be treated with particular caution.
Pneumonitis (inflammation of the lungs) including interstitial lung disease has been reported in patients receiving ELAHERE. Patients should be monitored for respiratory symptoms such as new or worsening cough, dyspnea (shortness of breath), or hypoxia. If pneumonitis is suspected, ELAHERE should be withheld pending diagnostic evaluation. If confirmed, ELAHERE should be permanently discontinued and appropriate treatment (typically corticosteroids) should be initiated.
Infusion-related reactions may occur, particularly during the first infusion. Symptoms may include fever, chills, flushing, rash, itching, shortness of breath, and hypotension. Premedication with antipyretics, antihistamines, and corticosteroids is recommended before each infusion to reduce the risk of infusion-related reactions. If a severe reaction occurs, the infusion should be stopped and appropriate medical management initiated.
Pregnancy and Breastfeeding
ELAHERE can cause fetal harm based on its mechanism of action. The cytotoxic payload DM4 disrupts microtubule function, which is essential for normal fetal development. Animal reproduction studies have not been conducted with mirvetuximab soravtansine, but based on the mechanism of action, the drug is expected to be embryotoxic and teratogenic. Women of reproductive potential should have a pregnancy test before starting treatment. Effective contraception must be used during treatment and for at least 7 months after the last dose. Male patients with female partners of reproductive potential should use effective contraception during treatment and for at least 4 months after the last dose. Patients should be advised not to breastfeed during treatment and for at least 7 months after the last dose, as it is not known whether mirvetuximab soravtansine or its metabolites are excreted in human breast milk.
Ophthalmic examinations (including visual acuity testing and slit-lamp examination) are mandatory before each dose of ELAHERE. You must use preservative-free lubricating eye drops at least 4 times daily starting from the day before each infusion and continuing for at least 72 hours after each dose. Do not wear contact lenses during treatment. Report any changes in your vision to your healthcare team immediately.
How Does ELAHERE Interact with Other Drugs?
Mirvetuximab soravtansine-gynx is a large-molecule antibody-drug conjugate, and its pharmacokinetic interactions differ from those of small-molecule drugs. The released DM4 catabolite is metabolized primarily by CYP3A4 enzymes. Therefore, concomitant use of strong CYP3A4 inhibitors may increase exposure to the cytotoxic DM4 payload, potentially increasing the risk of adverse effects. While formal drug interaction studies have not identified dose-limiting interactions, clinical caution is advised in several specific scenarios.
The MIRASOL trial allowed concomitant use of bevacizumab with ELAHERE, and higher rates of certain adverse events (particularly epistaxis, hypertension, and proteinuria) were observed in the combination group. While bevacizumab is not strictly contraindicated with ELAHERE, the combination requires careful monitoring and risk-benefit assessment. Additionally, because ELAHERE has immunosuppressive properties (it can reduce white blood cell counts), live vaccines should be avoided during treatment, as the immune response may be impaired and there is a risk of vaccine-strain infection.
Major Interactions
| Interacting Drug | Effect | Recommendation |
|---|---|---|
| Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin) | May increase DM4 exposure and risk of toxicity | Avoid concomitant use if possible; if unavoidable, monitor closely for increased adverse effects |
| Live vaccines (e.g., MMR, varicella, yellow fever) | Risk of vaccine-strain infection due to immunosuppression | Avoid live vaccines during treatment and until immune recovery |
| Other ocular toxic agents (e.g., hydroxychloroquine, amiodarone, tamoxifen) | Additive or synergistic ocular toxicity risk | Use with caution; increase frequency of ophthalmic monitoring |
Minor Interactions
| Interacting Drug | Effect | Recommendation |
|---|---|---|
| Bevacizumab | Increased rates of epistaxis, hypertension, and proteinuria when used together | Monitor blood pressure, urine protein, and for bleeding events; consider risk-benefit |
| Moderate CYP3A4 inhibitors (e.g., fluconazole, erythromycin, diltiazem) | May modestly increase DM4 exposure | Monitor for increased adverse effects; dose adjustment generally not required |
| Strong CYP3A4 inducers (e.g., rifampicin, phenytoin, carbamazepine) | May decrease DM4 exposure and potentially reduce efficacy | Avoid strong inducers if possible; consider alternative medications |
| Neurotoxic agents (e.g., vinca alkaloids, taxanes, platinum compounds) | Additive peripheral neuropathy risk | Monitor for neuropathy symptoms; consider timing of sequential therapies |
Patients should always provide their healthcare team with a complete list of all medications, supplements, and herbal products they are taking. This includes over-the-counter medications, vitamins, and dietary supplements. While ELAHERE has a relatively favorable drug interaction profile compared to many small-molecule anticancer agents, ongoing pharmacovigilance and individualized assessment remain important components of safe prescribing.
What Is the Correct Dosage of ELAHERE?
ELAHERE dosing is uniquely based on adjusted ideal body weight (AIBW) rather than actual body weight or body surface area. This weight-based dosing approach was chosen to optimize drug exposure across patients with varying body compositions. AIBW is calculated using a specific formula that takes into account the patient’s actual body weight, ideal body weight, and an adjustment factor. Your healthcare team will perform this calculation for each treatment cycle.
Adults
Standard Adult Dose
The recommended dosage is 6 mg/kg adjusted ideal body weight (AIBW), administered as an intravenous infusion once every 3 weeks (on Day 1 of each 21-day cycle). Treatment continues until disease progression or unacceptable toxicity.
- First infusion: Administered over approximately 60 minutes
- Subsequent infusions: May be given over 30 minutes if the first infusion was well tolerated
- AIBW calculation: AIBW = Ideal Body Weight (IBW) + 0.22 × (Actual Body Weight − IBW)
- Premedication: Antipyretic, antihistamine (H1 and H2 blocker), and dexamethasone (or equivalent) are given before each infusion
- Eye care: Preservative-free lubricating eye drops at least 4 times daily, starting the day before each infusion through at least 72 hours after
Dose Modifications
Dose modifications for ELAHERE include dose delays, dose reductions, and permanent discontinuation depending on the type and severity of adverse reactions. The prescribing information provides specific dose modification guidelines for ocular toxicity, peripheral neuropathy, pneumonitis, and other adverse reactions.
| Level | Dose | Notes |
|---|---|---|
| Starting dose | 6 mg/kg AIBW | Standard recommended dose |
| First reduction | 5 mg/kg AIBW | For Grade 2–3 ocular toxicity, Grade 2 neuropathy, or other Grade 3 adverse reactions |
| Second reduction | 4 mg/kg AIBW | For recurrent Grade 2–3 toxicity after first dose reduction |
| Discontinuation | N/A | If adverse reaction requires dose reduction below 4 mg/kg AIBW, or for Grade 4 ocular toxicity, any grade pneumonitis, or Grade 4 neuropathy |
Children
ELAHERE is not indicated for use in pediatric patients. The safety and efficacy of ELAHERE in patients under 18 years of age have not been established. Epithelial ovarian cancer is primarily a disease of adult women, and clinical trials of ELAHERE did not include pediatric patients.
Elderly
No specific dose adjustment is required for elderly patients. In the clinical trials leading to approval (SORAYA and MIRASOL), a substantial proportion of patients were aged 65 years and older, and no overall differences in safety or efficacy were observed between older and younger patients. However, elderly patients may be more susceptible to certain adverse effects, particularly ocular toxicity and peripheral neuropathy, and should be monitored closely throughout treatment.
Missed Dose
If a scheduled dose of ELAHERE is missed or delayed, it should be administered as soon as possible. There is no need to adjust the dose after a delay. The subsequent doses should continue to be administered at 3-week intervals from the date of the most recent dose. Treatment delays of up to 2 weeks for recovery from adverse events are common and specified in the dose modification guidelines. If a dose is delayed by more than 4 weeks due to persistent adverse effects, permanent discontinuation of ELAHERE may need to be considered.
Overdose
There is no specific antidote for ELAHERE overdose. In the event of an overdose, the patient should be closely monitored for signs and symptoms of adverse reactions, particularly ocular toxicity, peripheral neuropathy, and myelosuppression (low blood cell counts). Supportive care should be provided as clinically indicated. Given that ELAHERE is administered intravenously in a supervised healthcare setting, the risk of accidental overdose is low. Hemodialysis is not expected to significantly remove mirvetuximab soravtansine due to its large molecular size.
What Are the Side Effects of ELAHERE?
Like all medications, ELAHERE can cause side effects. The adverse event profile of ELAHERE has been well characterized through the pivotal clinical trials (SORAYA and MIRASOL) involving hundreds of patients. Understanding the frequency and nature of potential side effects helps patients and their healthcare teams make informed treatment decisions and enables prompt recognition and management of adverse events. The side effects listed below are organized by frequency category according to standard medical convention.
It is important to note that ocular (eye) toxicity is the most distinctive side effect of ELAHERE, occurring more frequently than with most other anticancer agents. This is related to the expression of folate receptors in corneal epithelial cells, which allows some uptake of the drug by these cells. The ocular effects are generally manageable with prophylactic measures (lubricating eye drops) and dose modifications, and many patients experience improvement or resolution after treatment discontinuation.
Very Common (>1/10 patients)
- Blurred vision / visual impairment
- Keratopathy (corneal changes)
- Dry eye
- Decreased visual acuity
- Fatigue / asthenia
- Nausea
- Diarrhea
- Abdominal pain
- Peripheral neuropathy (numbness, tingling)
- Decreased appetite
- Rash
- Headache
- Constipation
- Alopecia (hair thinning)
- Arthralgia (joint pain)
- Anemia (low red blood cells)
- Increased AST/ALT (liver enzyme elevation)
Common (1/10 – 1/100 patients)
- Pneumonitis / interstitial lung disease
- Infusion-related reactions
- Vomiting
- Stomatitis (mouth sores)
- Photophobia (light sensitivity)
- Eye pain / tearing
- Dyspnea (shortness of breath)
- Neutropenia (low white blood cells)
- Thrombocytopenia (low platelets)
- Lymphopenia (low lymphocytes)
- Hypokalemia (low potassium)
- Hypomagnesemia (low magnesium)
- Weight loss
- Urinary tract infection
- Myalgia (muscle pain)
Uncommon (1/100 – 1/1,000 patients)
- Corneal ulceration
- Severe visual loss
- Febrile neutropenia
- Severe infusion reactions (anaphylaxis-like)
- Hepatotoxicity (severe liver injury)
- Severe pneumonitis requiring hospitalization
Rare (<1/1,000 patients)
- Permanent vision changes
- Fatal pneumonitis
- Severe anaphylactic reactions
Most side effects of ELAHERE are manageable with appropriate dose modifications, supportive care, and prophylactic measures. Ocular toxicity, while common, is generally reversible in the majority of patients when managed with lubricating eye drops, dose delays, and dose reductions as specified in the prescribing information. Peripheral neuropathy may improve after dose reduction or treatment discontinuation, although some patients may experience persistent symptoms. Pneumonitis, while less common, requires prompt recognition and management including discontinuation of ELAHERE and initiation of corticosteroid therapy.
Patients should report any new or worsening symptoms to their healthcare team promptly, particularly changes in vision, new numbness or tingling in the extremities, or respiratory symptoms such as cough or shortness of breath. Regular blood tests and ophthalmic examinations throughout the treatment course enable early detection and management of adverse effects.
Seek immediate medical attention if you experience: sudden changes in vision or significant vision loss, severe difficulty breathing or persistent cough, signs of severe allergic reaction (swelling of face/throat, difficulty breathing, severe rash), high fever (above 38.5°C / 101.3°F) especially with low white blood cell counts, or severe abdominal pain.
How Should You Store ELAHERE?
ELAHERE is a hospital-administered medication, and storage is managed by the healthcare facility’s pharmacy. Patients do not need to store ELAHERE at home. However, understanding the storage requirements helps ensure that the medication maintains its potency and safety throughout the treatment course.
Unopened vials of ELAHERE should be stored in a refrigerator at 2°C to 8°C (36°F to 46°F). The vials must be kept in the original carton to protect from light exposure. ELAHERE must not be frozen. If accidentally frozen, the vial should be discarded and not used. The solution should be a clear to slightly opalescent, colorless to slightly yellow liquid. Prior to use, healthcare professionals should visually inspect the solution for particulate matter and discoloration; if either is observed, the vial should not be used.
Once diluted for intravenous infusion, the prepared ELAHERE solution may be stored at room temperature (20°C to 25°C / 68°F to 77°F) for up to 8 hours, or refrigerated at 2°C to 8°C for up to 24 hours from the time of preparation. The diluted solution should not be frozen. Any unused portion of the diluted infusion solution should be discarded. ELAHERE vials are single-use and contain no preservatives; any unused portion remaining in the vial after dose preparation should be discarded.
As with all medications, ELAHERE should be kept out of the reach of children. The medication should be disposed of in accordance with local and institutional requirements for cytotoxic waste. Do not dispose of ELAHERE in household waste or wastewater.
What Does ELAHERE Contain?
Active Ingredient
The active ingredient is mirvetuximab soravtansine-gynx, an antibody-drug conjugate consisting of a humanized IgG1 monoclonal antibody directed against folate receptor alpha, conjugated to the cytotoxic maytansinoid DM4 via a sulfo-SPP cleavable disulfide linker. The average drug-to-antibody ratio (DAR) is approximately 3.5 molecules of DM4 per antibody molecule. Mirvetuximab soravtansine-gynx is produced by conjugation of DM4 to the antibody in Chinese hamster ovary (CHO) cell-derived mirvetuximab, followed by purification.
Inactive Ingredients (Excipients)
- L-histidine
- L-histidine hydrochloride monohydrate
- Sucrose
- Polysorbate 20
- Water for injection
Available Presentations
ELAHERE is supplied as a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution for intravenous infusion in single-dose vials:
- 20 mg/4 mL (5 mg/mL) in a single-dose vial
- 100 mg/20 mL (5 mg/mL) in a single-dose vial
Manufacturer
ELAHERE was originally developed by ImmunoGen, Inc. (Waltham, Massachusetts, USA). Following the acquisition of ImmunoGen by AbbVie Inc. in 2024, ELAHERE is now marketed and distributed by AbbVie. The manufacturing and quality control processes remain under strict regulatory oversight by the FDA and EMA to ensure consistent product quality and safety.
Frequently Asked Questions About ELAHERE
ELAHERE (mirvetuximab soravtansine-gynx) is used to treat adult patients with folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have received one to three prior systemic treatment regimens. It is a targeted therapy that delivers a cell-killing agent directly to cancer cells expressing the FRα protein.
In the pivotal SORAYA trial, ELAHERE demonstrated an overall response rate (ORR) of approximately 32.4% (later confirmed), with a complete response rate of 4.8% in patients with FRα-high, platinum-resistant ovarian cancer. More importantly, the randomized MIRASOL trial showed that ELAHERE significantly improved both progression-free survival (median 5.62 vs 3.98 months; HR 0.65) and overall survival (median 16.46 vs 12.75 months; HR 0.67) compared with investigator’s choice chemotherapy, representing a clinically meaningful advance in this difficult-to-treat setting.
Ocular (eye) side effects are common with ELAHERE, affecting approximately 40–50% of patients. These may include blurred vision, dry eyes, corneal changes (keratopathy), light sensitivity, and decreased visual acuity. However, with proper prophylactic measures (preservative-free lubricating eye drops used at least 4 times daily), regular ophthalmic monitoring, and appropriate dose modifications when needed, most ocular side effects are manageable. The majority of ocular events are reversible, with most patients experiencing improvement after dose adjustment or treatment completion. Severe, permanent vision changes are rare.
Folate receptor alpha (FRα) testing is a laboratory test performed on a sample of your tumor tissue to determine whether your cancer cells express the FRα protein. ELAHERE works by targeting cancer cells that express FRα, so the drug is only effective in patients whose tumors have sufficient FRα expression. The test used is the VENTANA FOLR1 (RxDx) Assay, an immunohistochemistry (IHC) test that evaluates the percentage and intensity of FRα staining on tumor cells. To be eligible for ELAHERE, your tumor must meet a specific FRα expression threshold. Your oncologist will arrange this testing using tissue from a prior biopsy or surgical procedure.
ELAHERE is currently approved primarily as a single-agent therapy. In the MIRASOL trial, some patients received ELAHERE in combination with bevacizumab, which was permitted per the trial protocol. While the combination was feasible, higher rates of certain side effects (such as bleeding, high blood pressure, and protein in urine) were observed. Ongoing clinical trials are investigating ELAHERE in combination with other agents, including immune checkpoint inhibitors and other targeted therapies. Any combination use should be discussed with your oncologist based on the current evidence and your individual clinical situation.
Treatment with ELAHERE continues for as long as the cancer responds to therapy (does not progress) and the side effects remain manageable. There is no predetermined maximum number of treatment cycles. In the MIRASOL trial, the median duration of treatment was approximately 4.5 months (roughly 6 cycles), but some patients continued treatment for considerably longer. Your oncologist will monitor your disease status through regular imaging (CT or MRI scans) and blood tests (including CA-125 tumor marker) and will advise you on the appropriate duration of treatment based on your individual response and tolerability.
References
- U.S. Food and Drug Administration (FDA). ELAHERE (mirvetuximab soravtansine-gynx) Prescribing Information. Revised 2024. Available from: FDA Drug Label.
- European Medicines Agency (EMA). ELAHERE (mirvetuximab soravtansine) – Summary of Product Characteristics. Available from: EMA EPAR.
- Matulonis UA, Lorusso D, Oaknin A, et al. Mirvetuximab Soravtansine in FRα-Positive, Platinum-Resistant Ovarian Cancer (MIRASOL). N Engl J Med. 2023;389(23):2162–2174. doi:10.1056/NEJMoa2309169.
- Moore KN, Angelergues A, Konecny GE, et al. Mirvetuximab Soravtansine in FRα-Positive, Platinum-Resistant Ovarian Cancer (SORAYA). J Clin Oncol. 2023;41(13):2436–2445. doi:10.1200/JCO.22.01900.
- National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Ovarian Cancer Including Fallopian Tube Cancer and Primary Peritoneal Cancer. Version 1.2025.
- Colombo N, Sessa C, du Bois A, et al. ESMO-ESGO consensus conference recommendations on ovarian cancer: pathology and molecular biology, early and advanced stages, borderline tumours and recurrent disease. Ann Oncol. 2024;35(3):248–266.
- O’Malley DM, Matulonis UA, Birrer MJ, et al. Phase Ib study of mirvetuximab soravtansine, a folate receptor alpha (FRα)-targeting antibody-drug conjugate (ADC), in combination with bevacizumab in patients with platinum-resistant ovarian cancer. Gynecol Oncol. 2020;157(2):379–385.
- World Health Organization (WHO). WHO Model List of Essential Medicines – 23rd List. Geneva: WHO; 2023.
- Kalli KR, Oberg AL, Keeney GL, et al. Folate receptor alpha as a tumor target in epithelial ovarian cancer. Gynecol Oncol. 2008;108(3):619–626.
- Ab O, Whiteman KR, Bartle LM, et al. IMGN853, a Folate Receptor-α (FRα)–Targeting Antibody–Drug Conjugate, Exhibits Potent Targeted Antitumor Activity against FRα-Expressing Tumors. Mol Cancer Ther. 2015;14(7):1605–1613.
Editorial Team
This article was written and reviewed by the iMedic Medical Editorial Team, comprising licensed specialist physicians with expertise in gynecologic oncology, medical oncology, and clinical pharmacology.
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