Mirvetuximab soravtansine

From WikiProjectMed
Jump to navigation Jump to search
Mirvetuximab soravtansine
Mirvetuximab soravtansine.svg
Monoclonal antibody
TypeWhole antibody
SourceChimeric
Targetfolate receptor alpha
Names
Trade namesElahere
Other namesMirvetuximab soravtansine-gynx
Clinical data
Main usesOvarian cancer, fallopian tube cancer, primary peritoneal cancer[1]
Side effectsVision problems, tiredness, liver problems, nausea, abdominal pain, low white blood cells, peripheral neuropathy, diarrhea, constipation, low magnesium, low hemoglobin[1]
Routes of
use
Intravenous
Typical dose6 mg/kg ideal body weight q 3 wks[1]
External links
AHFS/Drugs.comMonograph
Legal
License data
Legal status

Mirvetuximab soravtansine, sold under the brand name Elahere, is a medication used to treat certain types of ovarian cancer, fallopian tube cancer, and primary peritoneal cancer.[1] Specifically it is for cases that are folate receptor alpha (FRα) positive that have failed other treatments.[1] It is given by gradual injection into a vein.[1]

Common side effects include vision problems, tiredness, liver problems, nausea, abdominal pain, low white blood cells, peripheral neuropathy, diarrhea, constipation, low magnesium, and low hemoglobin.[1] Other side effects may include pneumonitis.[1] Use in pregnancy may harm the baby.[1] It is a monoclonal antibody directed at FRα attached to a microtubule inhibitor.[1]

Mirvetuximab soravtansine was approved for medical use in the United States in 2022.[1] It is available as an orphan medication in Europe.[3] In the United States it costs about 25,000 USD every three weeks as of 2022.[4]

Medical uses

Mirvetuximab soravtansine is indicated for the treatment of adults 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.[1][2] Recipients are selected for therapy based on an FDA-approved test.[2] Corticosteroids, antihistamines, and acetaminophen are generally used before it is given to reduce side effects.[1]

Dosage

It is given at a dose of 6 mg/kg ideal body weight every three weeks.[1]

Side effects

The product labeling includes a boxed warning for eye problems.[1][2]

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.[2] Participants were permitted to receive up to three prior lines of systemic therapy.[2] All participants were required to have received bevacizumab.[2] The trial enrolled participants whose tumors were positive for FRα expression as determined by the above assay.[2] Participants were excluded if they had corneal disorders, ocular conditions requiring ongoing treatment, Grade >1 peripheral neuropathy, or noninfectious interstitial lung disease.[2]

Society and culture

Names

Mirvetuximab soravtansine is the international nonproprietary name (INN).[5]

References

  1. 1.00 1.01 1.02 1.03 1.04 1.05 1.06 1.07 1.08 1.09 1.10 1.11 1.12 1.13 1.14 1.15 "Elahere- mirvetuximab soravtansine injection, solution". DailyMed. 18 November 2022. Archived from the original on 4 December 2022. Retrieved 4 December 2022.
  2. 2.0 2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.8 "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. Archived from the original on 18 November 2022. Retrieved 18 November 2022. Public Domain This article incorporates text from this source, which is in the public domain.
  3. "Mirvetuximab soravtansine". SPS - Specialist Pharmacy Service. 27 March 2018. Archived from the original on 25 June 2022. Retrieved 16 December 2022.
  4. Satija, Bhanvi (15 November 2022). "Immunogen's $6,220 ovarian cancer drug to be shipped within days". Reuters. Archived from the original on 15 November 2022. Retrieved 16 December 2022.
  5. World Health Organization (2016). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 75". WHO Drug Information. 30 (1). hdl:10665/331046.

External links

Identifiers:
  • "Mirvetuximab soravtansine". Drug Information Portal. U.S. National Library of Medicine. Archived from the original on 2022-11-18. Retrieved 2022-12-04.
  • 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