Monoclonal antibody | |
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Type | Whole antibody |
Source | Chimeric |
Target | folate receptor alpha |
Clinical data | |
Trade names | Elahere |
Other names | mirvetuximab 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]
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]
The product labeling includes a boxed warning for ocular toxicity. [2] [3]
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]
Mirvetuximab soravtansine is the international nonproprietary name (INN). [8]
Ovarian cancer is a cancerous tumor of an ovary. It may originate from the ovary itself or more commonly from communicating nearby structures such as fallopian tubes or the inner lining of the abdomen. The ovary is made up of three different cell types including epithelial cells, germ cells, and stromal cells. When these cells become abnormal, they have the ability to divide and form tumors. These cells can also invade or spread to other parts of the body. When this process begins, there may be no or only vague symptoms. Symptoms become more noticeable as the cancer progresses. These symptoms may include bloating, vaginal bleeding, pelvic pain, abdominal swelling, constipation, and loss of appetite, among others. Common areas to which the cancer may spread include the lining of the abdomen, lymph nodes, lungs, and liver.
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