Doctors know that ovarian cancer begins when cells in or near the ovaries develop changes (mutations) in their DNA. A cell’s DNA contains the instructions that tell the cell what to do. The changes tell the cells to grow and multiply quickly, creating a mass (tumor) of cancer cells. The cancer cells continue living when healthy cells would die. They can invade nearby tissues and break off from an initial tumor to spread (metastasize) to other parts of the body.
Folate receptor alpha (FRα) is an actionable biomarker that is important to assess in patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer. ELAHERE™ (mirvetuximab soravtansine-gynx) is the first and only treatment indicated for adult patients with folate receptor-alpha (FRα) positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer (EOC), who have received one to three prior systemic treatment regimens.
The VENTANA RxDx FOLR1 IHC assay is an FDA-approved companion diagnostic assay that can detect the level of FRα expression. Patients with EOC whose tumors highly express FRα (≥75% tumor cells staining at 2+/3+ intensity) may be eligible for treatment with ELAHERE.
What is the Program?
AbbVie offers the ImmunoGen FR-ASSIST™ FOLR1 Immunohistochemistry (IHC) Sponsored Testing Program as a way to increase access to testing for patients with epithelial ovarian, fallopian tube or primary peritoneal cancer (EOC). The program also assists healthcare providers with making informed treatment decisions for these patients. Under an arrangement with ImmunoGen, FOLR1 IHC testing is available at no cost for patients with EOC that meet certain eligibility requirements.
– While AbbVie provides financial support for this program, tests and services are performed by diagnostic labs.
Healthcare professionals must confirm that patients meet certain criteria to use the program.
– AbbVie receives de-identified aggregate data from this program, but at no time does the sponsor receive patient-identifiable information. The sponsor may use healthcare professional contact information for research and commercial purposes.
– Healthcare professionals or patients who use this program have no obligation to recommend, purchase, order, prescribe, promote, administer, use, or support any sponsor product.
– No patients, healthcare professionals, or payers, including government payers, are billed for this program.
Patients must meet all of the following criteria to be eligible:
Patients meeting the above eligibility criteria, as well as their treating health care providers, are not required to order, purchase, prescribe, and/or obtain any other product or service from ImmunoGen, Labcorp or any of their affiliates.
All eligible patients who enroll in the FR-ASSIST™ Sponsored Testing Program will receive one FOLR1 IHC test (test code 453027) at no charge.
To place your paper-based order, complete the NeoGenomics paper test request form for FOLR1, and fax it to 310-876-3216, or insert the form in the NeoGenomics specimen collection kit before shipment.
To place your paper-based order, complete the Labcorp intake form for FOLR1, and a program representative will be in touch with you to provide specifics about the program.
To place your paper-based order, complete the Myriad Genetics paper test request form for FOLR1, and fax it to 310-876-3216, or insert the form in the Myriad Genetics specimen collection kit before shipment.
Program Information
Folate receptor alpha (FRα) is an actionable therapeutic target that is commonly expressed in ovarian cancer. Approximately 35% of ovarian cancer patients are expected to be positive for FRα expression by the VENTANA FOLR1 (FOLR1-2.1) RxDx Assay.
With the approval of ELAHERE™ (mirvetuximab soravtansine-gynx), FRα is now an actionable target in platinum-resistant ovarian cancer.
Yes; the labs listed above are validated to run the VENTANA FOLR1 (FOLR1-2.1) RxDx Assay, the FDA-approved companion diagnostic for ELAHERE™.
The VENTANA FOLR1 (FOLR1-2.1) RxDx Assay is intended for use in the assessment of FRα in ovarian cancer, including epithelial ovarian cancer, primary peritoneal cancer or primary fallopian tube cancer. Because FRα is generally stable through the course of treatment, testing can be done upon diagnosis of ovarian cancer or at progression.
Yes; Fresh or archival ovarian cancer tissue is acceptable for FOLR1 IHC CDx testing.
The performing labs offer FOLR1 IHC CDx testing on formalin-fixed paraffin-embedded (FFPE) tumor resection or biopsy samples. Ovarian cancer (including epithelial ovarian cancer, primary peritoneal cancer and primary fallopian tube cancer) tissue is required. The paraffin block is preferred. Alternatively, send One (1) unbaked, unstained slide for H&E staining (required) and two to three (2-3) positively charged unstained slides (all cut at 4-5 microns). Please use positively-charged slides and 10% NBF fixative. Do not use zinc fixatives or send decalcified specimens.
Results are typically ready in 3-5 days from the time the specimen is received at the performing lab and will be sent to the ordering physician’s office or laboratory by their preferred method of delivery.
No patient, health care program, or beneficiary shall be billed for this test as part of the testing program.
Yes. Labcorp and NeoGenomics can procure the sample block from the designated pathology laboratory indicated in the completed test request form.
Myriad Genetics and PathAI Diagnostics require the block to be requested by the ordering physician. A shipping slip will be supplied.
At AbbVie, we are committed to transforming standards of care for multiple blood cancers while advancing a dynamic pipeline of investigational therapies across a range of cancer types. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potential breakthrough medicines. We are evaluating more than 20 investigational medicines in over 300 clinical trials across some of the world’s most widespread and debilitating cancers. As we work to have a remarkable impact on people’s lives, we are committed to exploring solutions to help patients obtain access to our cancer medicines. For more information, please visit http://www.abbvie.com/oncology.
ELAHERE® (mirvetuximab soravtansine-gynx) is a first-in-class antibody-drug conjugate (ADC) developed by ImmunoGen for the treatment of folate receptor-alpha (FRα) positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. ELAHERE combines a folate receptor alpha-binding antibody with a potent cytotoxic agent designed to selectively target and kill cancer cells. It is administered to patients who have received one to three prior systemic treatment regimens and is the first FDA-approved ADC for this indication. The approval is based on tumor response rate and duration of response, with continued approval contingent upon confirmatory trials. ELAHERE has demonstrated significant improvements in progression-free survival and overall response rates compared to standard chemotherapy, offering a promising new option for this challenging to treat cancer. However, it carries a boxed warning for severe ocular toxicity, including visual impairment and keratopathy, and requires regular ophthalmic examinations and prophylactic eye treatments during therapy.
