Mirvetuximab soravtansine, sold under the brand name Elahere, is a

medication Medication (also called medicament, medicine, pharmaceutical drug, medicinal product, medicinal drug or simply drug) is a drug used to medical diagnosis, diagnose, cure, treat, or preventive medicine, prevent disease. Drug therapy (pharmaco ...

used as a treatment for

epithelial ovarian cancer Surface epithelial-stromal tumors are a class of ovarian neoplasms that may be benign or malignant. Neoplasms in this group are thought to be derived from the ovarian surface epithelium (modified peritoneum) or from :wikt:ectopic, ectopic endometri ...

fallopian tube cancer Primary fallopian tube cancer (PFTC), also known as tubal cancer, is a malignant neoplasm that originates from the fallopian tube. Along with primary ovarian and peritoneal carcinomas, it is grouped under epithelial ovarian cancers; cancers of th ...

, or

primary peritoneal cancer Primary peritoneal cancer or carcinoma is also known as serous surface papillary carcinoma, primary peritoneal carcinoma, extra-ovarian serous carcinoma, primary serous papillary carcinoma, and psammomacarcinoma. It was historically classified und ...

. Mirvetuximab soravtansine is a folate receptor alpha directed antibody and microtubule inhibitor conjugate. 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. Mirvetuximab soravtansine was approved for medical use in the United States in November 2022. The US

Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respo ...

(FDA) considers it to be a

first-in-class medication A first-in-class medication is a prototype drug that uses a "new and unique mechanism of action" to treat a particular medical condition. While the Food and Drug Administration's Center for Drug Evaluation and Research tracks first-in-class medic ...

Medical uses

Mirvetuximab soravtansine is

indicated In medicine, an indication is a valid reason to use a certain test, medication, procedure, or surgery. There can be multiple indications to use a procedure or medication. An indication can commonly be confused with the term diagnosis. A diagnosis ...

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. Recipients are selected for therapy based on an FDA-approved test.

Adverse effects

The product labeling includes a

boxed warning In the United States, a boxed warning (sometimes "black box warning", colloquially) is a type of warning that appears near the beginning of the package insert for certain prescription drugs, so called because the U.S. Food and Drug Administratio ...

for ocular toxicity.

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. Participants were permitted to receive up to three prior lines of systemic therapy. All participants were required to have received

bevacizumab Bevacizumab, sold under the brand name Avastin among others, is a monoclonal antibody medication used to treat a number of types of cancers and a specific eye disease. For cancer, it is given by slow injection into a vein (intravenous) and use ...

. The trial enrolled participants whose tumors were positive for FRα expression as determined by the above assay. Participants were excluded if they had corneal disorders, ocular conditions requiring ongoing treatment, Grade >1 peripheral neuropathy, or noninfectious interstitial lung disease. 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. Participants were permitted to receive up to three prior lines of systemic therapy. The trial enrolled participants whose tumors were positive for FRα expression as determined by the VENTANA FOLR1 (FOLR1-2.1) RxDx Assay. 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. The results from this trial satisfy the post-marketing requirement of the previous accelerated approval for mirvetuximab soravtansine-gynx.

Society and culture

Legal status

In September 2024, the

Committee for Medicinal Products for Human Use The Committee for Medicinal Products for Human Use (CHMP), formerly known as the Committee for Proprietary Medicinal Products (CPMP), is the European Medicines Agency's committee responsible for elaborating the agency's opinions on all issues regar ...

of the

European Medicines Agency The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of pharmaceutical products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products ...

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. The applicant for this medicinal product is AbbVie Deutschland GmbH & Co. KG. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged. Mirvetuximab soravtansine was authorized for use in the European Union in November 2024.

Names

Mirvetuximab soravtansine is the international nonproprietary name (INN).

References

External links

* * {{DEFAULTSORT:Mirvetuximab Soravtansine Monoclonal antibodies for tumors Antibody-drug conjugates Drugs developed by AbbVie