Mirvetuximab soravtansine

Mirvetuximab soravtansine
Monoclonal antibody
Type	Whole antibody
Source	Chimeric
Target	folate receptor alpha
Clinical data
Trade names	Elahere
Other names	mirvetuximab soravtansine-gynx
License data	US DailyMed: Mirvetuximab soravtansine;
Routes of; administration	Intravenous
ATC code	L01FX26 (WHO) ;
Legal status
Legal status	US: WARNINGRx-only; EU: Rx-only;
Identifiers
CAS Number	1453084-37-1;
DrugBank	DB12489;
UNII	98DE7VN88D;
KEGG	D10954;

Mirvetuximab soravtansine, sold under the brand name Elahere, is a medication used as a treatment for epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.^[2]^[5] Mirvetuximab soravtansine is a folate receptor alpha directed antibody and microtubule inhibitor conjugate.^[5]^[6]

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.^[5]

Mirvetuximab soravtansine was approved for medical use in the United States in November 2022.^[5]^[7] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication.^[8]^[9]

Medical uses

Mirvetuximab soravtansine is indicated for the treatment of adults 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.^[2]^[5]^[6] Recipients are selected for therapy based on an FDA-approved test.^[5]^[6]

Adverse effects

The product labeling includes a boxed warning for ocular toxicity.^[2]^[5]

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.^[5] Participants were permitted to receive up to three prior lines of systemic therapy.^[5] All participants were required to have received bevacizumab.^[5] The trial enrolled participants whose tumors were positive for FRα expression as determined by the above assay.^[5] Participants were excluded if they had corneal disorders, ocular conditions requiring ongoing treatment, Grade >1 peripheral neuropathy, or noninfectious interstitial lung disease.^[5]

Efficacy was evaluated in Study 0416 (MIRASOL, NCT04209855), a multicenter, open-label, active-controlled, randomized, two-arm trial in 453 participants with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer.^[6] Participants were permitted to receive up to three prior lines of systemic therapy.^[6] The trial enrolled participants whose tumors were positive for FRα expression as determined by the VENTANA FOLR1 (FOLR1-2.1) RxDx Assay.^[6] Participants were randomized (1:1) to receive mirvetuximab soravtansine-gynx 6 mg/kg (based on adjusted ideal body weight) as an intravenous infusion every 3 weeks or investigator’s choice of chemotherapy (paclitaxel, pegylated liposomal doxorubicin, or topotecan) until disease progression or unacceptable toxicity.^[6] The results from this trial satisfy the post-marketing requirement of the previous accelerated approval for mirvetuximab soravtansine-gynx.^[6]

Society and culture

Legal status

In September 2024, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Elahere, intended for the treatment of adults with folate receptor-alpha (FRα) positive epithelial ovarian, fallopian tube and primary peritoneal cancer.^[3] The applicant for this medicinal product is AbbVie Deutschland GmbH & Co. KG.^[3] Mirvetuximab soravtansine was authorized for use in the European Union in November 2024.^[4]

Names

Mirvetuximab soravtansine is the international nonproprietary name (INN).^[10]

References

^ "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.
^ ^a ^b ^c ^d "Elahere- mirvetuximab soravtansine injection, solution". DailyMed. 18 November 2022. Retrieved 4 December 2022.
^ ^a ^b ^c "Elahere EPAR". European Medicines Agency (EMA). 19 September 2024. Retrieved 21 September 2024. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
^ ^a ^b "Elahere PI". Union Register of medicinal products. 15 November 2024. Retrieved 20 November 2024.
^ ^a ^b ^c ^d ^e ^f ^g ^h ⁱ ^j ^k ^l "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 (FDA). 14 November 2022. Retrieved 18 November 2022. This article incorporates text from this source, which is in the public domain.
^ ^a ^b ^c ^d ^e ^f ^g ^h "FDA approves mirvetuximab soravtansine-gynx for FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer". U.S. Food and Drug Administration (FDA). 22 March 2024. Retrieved 23 March 2024. This article incorporates text from this source, which is in the public domain.
^ Heo YA (February 2023). "Mirvetuximab Soravtansine: First Approval". Drugs. 83 (3): 265–273. doi:10.1007/s40265-023-01834-3. PMID 36656533. S2CID 255972733.
^ "Advancing Health Through Innovation: New Drug Therapy Approvals 2022". U.S. Food and Drug Administration (FDA). 10 January 2023. Retrieved 22 January 2023. This article incorporates text from this source, which is in the public domain.
^ New Drug Therapy Approvals 2022 (PDF). U.S. Food and Drug Administration (FDA) (Report). January 2024. Archived from the original on 14 January 2024. Retrieved 14 January 2024. This article incorporates text from this source, which is in the public domain.
^ 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

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
Clinical trial number NCT04209855 for "A Study of Mirvetuximab Soravtansine vs. Investigator's Choice of Chemotherapy in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression (MIRASOL)" at ClinicalTrials.gov

[FDA-AllBoxedWarnings-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.

[Elahere_FDA_label-2] "Elahere- mirvetuximab soravtansine injection, solution". DailyMed. 18 November 2022. Retrieved 4 December 2022.

[Elahere_EPAR-3] "Elahere EPAR". European Medicines Agency (EMA). 19 September 2024. Retrieved 21 September 2024. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.

[Elahere_PI-4] "Elahere PI". Union Register of medicinal products. 15 November 2024. Retrieved 20 November 2024.

[FDA_20221114-5] ^ ^a ^b ^c ^d ^e ^f ^g ^h ⁱ ^j ^k ^l "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 (FDA). 14 November 2022. Retrieved 18 November 2022. This article incorporates text from this source, which is in the public domain.

[FDA_20240322-6] ^ ^a ^b ^c ^d ^e ^f ^g ^h "FDA approves mirvetuximab soravtansine-gynx for FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer". U.S. Food and Drug Administration (FDA). 22 March 2024. Retrieved 23 March 2024. This article incorporates text from this source, which is in the public domain.

[pmid36656533-7] Heo YA (February 2023). "Mirvetuximab Soravtansine: First Approval". Drugs. 83 (3): 265–273. doi:10.1007/s40265-023-01834-3. PMID 36656533. S2CID 255972733.

[New_Drug_Therapy_Approvals_2022-8] "Advancing Health Through Innovation: New Drug Therapy Approvals 2022". U.S. Food and Drug Administration (FDA). 10 January 2023. Retrieved 22 January 2023. This article incorporates text from this source, which is in the public domain.

[9] New Drug Therapy Approvals 2022 (PDF). U.S. Food and Drug Administration (FDA) (Report). January 2024. Archived from the original on 14 January 2024. Retrieved 14 January 2024. This article incorporates text from this source, which is in the public domain.

[10] World Health Organization (2016). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 75". WHO Drug Information. 30 (1). hdl:10665/331046.

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