Mirvetuximab soravtansine
Monoclonal antibody
TypeWhole antibody
SourceChimeric
Targetfolate receptor alpha
Clinical data
Trade namesElahere
Other namesmirvetuximab soravtansine-gynx
License data
Routes of
administration		Intravenous
ATC code
Legal status
Legal status
Identifiers
CAS Number
UNII
KEGG

Mirvetuximab soravtansine, sold under the brand name Elahere, is a medication used as a treatment for fallopian tube cancer or primary peritoneal cancer.[2][3] Mirvetuximab soravtansine is a folate receptor alpha directed antibody and microtubule inhibitor conjugate.[3]

The most common adverse reactions, including laboratory abnormalities, were vision impairment, fatigue, increased aspartate aminotransferase, nausea, increased alanine aminotransferase, keratopathy, abdominal pain, decreased lymphocytes, peripheral neuropathy, diarrhea, decreased albumin, constipation, increased alkaline phosphatase, dry eye, decreased magnesium, decreased leukocytes, decreased neutrophils, and decreased hemoglobin.[3]

Mirvetuximab soravtansine was approved for medical use in the United States in November 2022.[3][4] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication.[5]

Medical uses

Mirvetuximab soravtansine is indicated for the treatment of adults with folate receptor alpha (FRα) positive, platinum-resistant epithelial ovarian,[6][7] fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens.[2][3] Recipients are selected for therapy based on an FDA-approved test.[3]

Adverse effects

The product labeling includes a boxed warning for ocular toxicity.[2][3]

History

Efficacy was evaluated in Study 0417 (NCT04296890), a single-arm trial of 106 participants with FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer.[3] Participants were permitted to receive up to three prior lines of systemic therapy.[3] All participants were required to have received bevacizumab.[3] The trial enrolled participants whose tumors were positive for FRα expression as determined by the above assay.[3] Participants were excluded if they had corneal disorders, ocular conditions requiring ongoing treatment, Grade >1 peripheral neuropathy, or noninfectious interstitial lung disease.[3]

Society and culture

Names

Mirvetuximab soravtansine is the international nonproprietary name (INN).[8]

References

  1. ↑ "FDA-sourced list of all drugs with black box warnings (Use Download Full Results and View Query links.)". nctr-crs.fda.gov. FDA. Retrieved 22 October 2023.
  2. 1 2 3 4 "Elahere- mirvetuximab soravtansine injection, solution". DailyMed. 18 November 2022. Retrieved 4 December 2022.
  3. 1 2 3 4 5 6 7 8 9 10 11 12 13 "FDA grants accelerated approval to mirvetuximab soravtansine-gynx for FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or peritoneal cancer". U.S. Food and Drug Administration. 14 November 2022. Retrieved 18 November 2022. Public Domain This article incorporates text from this source, which is in the public domain.
  4. ↑ Heo YA (February 2023). "Mirvetuximab Soravtansine: First Approval". Drugs. 83 (3): 265–273. doi:10.1007/s40265-023-01834-3. PMID 36656533. S2CID 255972733.
  5. ↑ "Advancing Health Through Innovation: New Drug Therapy Approvals 2022". U.S. Food and Drug Administration (FDA). 10 January 2023. Retrieved 22 January 2023. Public Domain This article incorporates text from this source, which is in the public domain.
  6. ↑ Porter RL, Matulonis UA (2023). "Mirvetuximab soravtansine for platinum-resistant epithelial ovarian cancer". Expert Review of Anticancer Therapy. 23 (8): 783–796. doi:10.1080/14737140.2023.2236793. PMID 37458180. S2CID 259947077.
  7. ↑ Gonzalez-Ochoa E, Veneziani AC, Oza AM (2023). "Mirvetuximab Soravtansine in Platinum-Resistant Ovarian Cancer". Clinical Medicine Insights. Oncology. 17: 11795549231187264. doi:10.1177/11795549231187264. PMC 10387675. PMID 37528890.
  8. ↑ World Health Organization (2016). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 75". WHO Drug Information. 30 (1). hdl:10665/331046.
  • "Mirvetuximab soravtansine". Drug Information Portal. U.S. National Library of Medicine.
  • Clinical trial number NCT04296890 for "A Study of Mirvetuximab Soravtansine in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression (SORAYA)" at ClinicalTrials.gov


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