{"entity":{"id":"mirvetuximab-soravtansine","kind":"drug","name":"Mirvetuximab soravtansine","aka":[],"tldr":"Mirvetuximab soravtansine (Elahere) is the first ADC for ovarian cancer, for tumours with high folate receptor alpha.","summary":"Mirvetuximab soravtansine (Elahere) is an anti-folate-receptor-alpha antibody carrying the maytansinoid DM4 (drug-to-antibody ratio about 3.5) through a cleavable sulfo-SPDB disulfide linker, and the released payload crosses membranes to kill neighbouring cells. It is the first ADC for ovarian cancer, given at 6 mg/kg every 3 weeks for FRα-high platinum-resistant disease. Accelerated approval in 2022 rested on SORAYA, and full approval in 2024 followed MIRASOL, which showed overall survival of 16.5 versus 12.7 months against chemotherapy; EMA approval came in late 2024. Ocular toxicity defines the side-effect profile, with blurred vision in 45 percent and keratopathy in 37 percent of MIRASOL patients, so eye examinations and steroid and lubricating drops are built into treatment. Combination and earlier-line trials are ongoing. It works in ovarian cancer at the price of careful eye care.","status":"approved","asOf":"2026-09-04","wikipedia":"https://en.wikipedia.org/wiki/Mirvetuximab_soravtansine","links":[{"label":"FDA label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Mirvetuximab%20soravtansine"}],"tags":[],"related":["folr1-expression"],"cancers":["ovarian","high-grade-serous-ovarian-cancer","platinum-resistant-ovarian-cancer"],"sections":[],"technologies":["adc"],"targets":["folr1"],"drugs":[],"companies":["abbvie"],"institutions":[],"pathways":[],"terms":["sulfo-spdb","ocular-toxicity"],"trials":["nct06682988","nct06365853","nct05456685","nct06890338","nct06390995","nct07059845","nct04274426"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Elahere","modality":"ADC","payload":"DM4 (maytansinoid), DAR ~3.5","linker":"Sulfo-SPDB, cleavable disulfide","mechanism":"Anti-FRα antibody with DM4; bystander-capable after disulfide cleavage.","approvals":[{"region":"US","year":2022,"indication":"FRα-high platinum-resistant ovarian cancer (full approval 2024)"},{"region":"EU","year":2024,"indication":"FRα+ platinum-resistant ovarian; 14 Nov 2024"}],"mechanismSteps":["Antibody binds Folate receptor alpha on the tumour cell surface","Receptor-ADC complex is internalised by endocytosis","Trafficked to the lysosome; linker is cleaved or antibody degraded","DM4 is released inside the cell","Microtubule assembly is blocked; mitosis arrests","Tumour cell dies by apoptosis","Membrane-permeable payload diffuses to kill neighbouring antigen-negative cells (bystander effect)"],"dosing":{"route":"IV infusion","schedule":"6 mg/kg adjusted ideal body weight every 3 weeks","modifications":"Hold for grade 2 keratopathy or blurred vision until grade ≤1; discontinue for grade 4 ocular events","monitoring":"Ophthalmic exam at baseline and every other cycle for 8 cycles; prophylactic steroid and lubricating eye drops","source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=00c424b5-6ccd-48ab-9e88-1986451120e2"},"toxicity":[{"event":"AST increased","anyGradePct":57,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=00c424b5-6ccd-48ab-9e88-1986451120e2","note":"MIRASOL; all-grade rates"},{"event":"Fatigue","anyGradePct":47,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=00c424b5-6ccd-48ab-9e88-1986451120e2","note":"MIRASOL; all-grade rates"},{"event":"Blurred vision","anyGradePct":45,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=00c424b5-6ccd-48ab-9e88-1986451120e2","note":"MIRASOL; all-grade rates"},{"event":"ALT increased","anyGradePct":38,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=00c424b5-6ccd-48ab-9e88-1986451120e2","note":"MIRASOL; all-grade rates"},{"event":"Keratopathy","anyGradePct":37,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=00c424b5-6ccd-48ab-9e88-1986451120e2","note":"MIRASOL; all-grade rates"},{"event":"Peripheral neuropathy","anyGradePct":37,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=00c424b5-6ccd-48ab-9e88-1986451120e2","note":"MIRASOL; all-grade rates"},{"event":"Abdominal pain","anyGradePct":34,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=00c424b5-6ccd-48ab-9e88-1986451120e2","note":"MIRASOL; all-grade rates"},{"event":"Dry eye","anyGradePct":29,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=00c424b5-6ccd-48ab-9e88-1986451120e2","note":"MIRASOL; all-grade rates"},{"event":"Diarrhoea","anyGradePct":29,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=00c424b5-6ccd-48ab-9e88-1986451120e2","note":"MIRASOL; all-grade rates"},{"event":"Nausea","anyGradePct":27,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=00c424b5-6ccd-48ab-9e88-1986451120e2","note":"MIRASOL; all-grade rates"}],"access":[{"country":"US","reimbursement":"Medicare Part B (physician-administered); commercial plans per formulary","assistance":"https://www.elahere.com","source":"https://www.cms.gov/medicare/payment/part-b-drugs/asp-pricing-files","asOf":"2026-09-06"},{"country":"UK","reimbursement":"NICE: recommended for FRα-high platinum-resistant ovarian cancer (2025)","source":"https://www.nice.org.uk/guidance/published?ngt=Technology%20appraisal%20guidance","asOf":"2026-09-06"}],"regulatoryEvents":[{"date":"2022-11-14","type":"accelerated-approval","region":"US","note":"Accelerated approval, FRα-high platinum-resistant ovarian cancer (SORAYA)","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications","indication":"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"},{"date":"2024-03-22","type":"conversion","region":"US","note":"Full approval with OS benefit (MIRASOL)","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications","indication":"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"},{"date":"2024-11","type":"approval","region":"EU","note":"EMA approval","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"}]},"route":"/drugs/mirvetuximab-soravtansine/","neighbours":{"biomarker":[{"id":"folr1-expression","kind":"biomarker","name":"Folate receptor alpha expression (FRα-positive, PS2+ >= 75%)","route":"/biomarkers/folr1-expression/"}],"cancer":[{"id":"high-grade-serous-ovarian-cancer","kind":"cancer","name":"High-grade serous ovarian cancer","route":"/cancers/high-grade-serous-ovarian-cancer/"},{"id":"ovarian","kind":"cancer","name":"Ovarian cancer","route":"/cancers/ovarian/"},{"id":"platinum-resistant-ovarian-cancer","kind":"cancer","name":"Platinum-resistant ovarian cancer","route":"/cancers/platinum-resistant-ovarian-cancer/"}],"technology":[{"id":"adc","kind":"technology","name":"Antibody-drug conjugate (ADC)","route":"/technologies/adc/"}],"target":[{"id":"folr1","kind":"target","name":"Folate receptor alpha","route":"/targets/folr1/"}],"company":[{"id":"abbvie","kind":"company","name":"AbbVie (incl. ImmunoGen, Capstan)","route":"/companies/abbvie/"},{"id":"gog-foundation","kind":"company","name":"GOG Foundation","route":"/companies/gog-foundation/"}],"term":[{"id":"dm4","kind":"term","name":"DM4","route":"/terms/dm4/"},{"id":"ocular-toxicity","kind":"term","name":"Ocular toxicity (keratopathy, blurred vision)","route":"/terms/ocular-toxicity/"},{"id":"sulfo-spdb","kind":"term","name":"Sulfo-SPDB (disulfide)","route":"/terms/sulfo-spdb/"},{"id":"tubulin-inhibitor-payloads","kind":"term","name":"Tubulin inhibitor payloads","route":"/terms/tubulin-inhibitor-payloads/"}],"trial":[{"id":"nct06365853","kind":"trial","name":"A Study of Ocular Toxicity Evaluation and Mitigation During Treatment With Mirvetuximab Soravtansine in Participants With Recurrent Ovarian Cancer Wit","route":"/trials/nct06365853/"},{"id":"nct06390995","kind":"trial","name":"A Study of TAK-853 in Adult Participants With Folate Receptor Alpha-Positive Advanced Ovarian Cancer And Other Solid Tumors","route":"/trials/nct06390995/"},{"id":"nct06682988","kind":"trial","name":"A Study to Assess Adverse Events and Change in Disease Activity in Participants With Platinum-Resistant Advanced High-Grade Epithelial Ovarian, Primar","route":"/trials/nct06682988/"},{"id":"nct07059845","kind":"trial","name":"A Study to Assess Adverse Events and Change in Disease Activity of Multiple Treatment Combinations With Intravenous Mirvetuximab Soravtansine in Adult","route":"/trials/nct07059845/"},{"id":"nct06890338","kind":"trial","name":"A Study to Assess Anti-Tumor Activity of Intravenously (IV) Infused Carboplatin With Mirvetuximab Soravtansine in Participants With Newly Diagnosed Fo","route":"/trials/nct06890338/"},{"id":"mirasol","kind":"trial","name":"MIRASOL / GOG-3045","route":"/trials/mirasol/"},{"id":"nct04274426","kind":"trial","name":"Mirvetuximab Soravtansine (IMGN853), in Folate Receptor Alpha (FRα) High Recurrent Ovarian Cancer","route":"/trials/nct04274426/"},{"id":"nct05456685","kind":"trial","name":"Mirvetuximab Soravtansine (MIRV) With Carboplatin in Second-line Treatment of Folate Receptor Alpha (FRα) Expressing, Platinum-sensitive Epithelial Ov","route":"/trials/nct05456685/"},{"id":"nct07825753","kind":"trial","name":"Protein-Matched ADC or PDC Umbrella Trial in Advanced Pancreatic and Breast Cancer","route":"/trials/nct07825753/"},{"id":"soraya","kind":"trial","name":"SORAYA","route":"/trials/soraya/"}],"idea":[{"id":"idea-tr1-adc-dose-and-schedule-optimisation","kind":"idea","name":"Dose and schedule optimisation trials specific to antibody-drug conjugates","route":"/ideas/idea-tr1-adc-dose-and-schedule-optimisation/"},{"id":"idea-fra-adc-sequencing-ovarian","kind":"idea","name":"Sequence folate-receptor ADCs by payload class","route":"/ideas/idea-fra-adc-sequencing-ovarian/"}],"roadmap":[{"id":"adc-generations","kind":"roadmap","name":"ADC roadmap: from Mylotarg to bispecific and dual-payload ADCs","route":"/roadmaps/adc-generations/"}],"person":[{"id":"kathleen-moore","kind":"person","name":"Kathleen N. Moore","route":"/people/kathleen-moore/"},{"id":"ursula-matulonis","kind":"person","name":"Ursula A. Matulonis","route":"/people/ursula-matulonis/"}],"paper":[{"id":"paper-mirasol-nejm-2023","kind":"paper","name":"MIRASOL: mirvetuximab soravtansine versus chemotherapy in folate receptor alpha-high platinum-resistant ovarian cancer","route":"/key-papers/paper-mirasol-nejm-2023/"}],"institution":[{"id":"stephenson-oklahoma","kind":"institution","name":"Stephenson Cancer Center, OU Health","route":"/institutions/stephenson-oklahoma/"}],"pathway":[{"id":"mitotic-spindle-checkpoint","kind":"pathway","name":"Mitosis & the spindle assembly checkpoint","route":"/pathways/mitotic-spindle-checkpoint/"}]}}