This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: VENTANA MMR RxDx Panel
PMA Applicant: Ventana Medical Systems, Inc.
Address: 1910 East Innovation Park Drive, Tucson, AZ 85755
Approval Date: April 22, 2021
Approval Letter: Approval Order
What is it?
VENTANA MMR RxDx Panel is a laboratory test designed to detect mismatch repair (MMR) proteins (MSH6, PMS2, MSH2 and MLH1) in patients diagnosed with endometrial cancer.
If the MMR proteins are not present, it indicates a patient with endometrial cancer is eligible for treatment with JEMPERLI (dostarlimab) . This drug is used to treat recurring or advanced endometrial cancer when one or more of the MMR proteins are absent.
How does it work?
A doctor takes a small sample of endometrial cancer tissue from the patient and sends it to a laboratory for testing. The laboratory treats a small slice of the tissue with the VENTANA MMR RxDx test. If the sample has MMR proteins, it stains dark brown. If the sample does not have MMR proteins, it will not have any staining. The lab clinician (pathologist) sends a report to the doctor to let them know if MMR proteins were absent or present in the slice.
When is it used?
Doctors use VENTANA MMR RxDx Panel to help decide whether a patient with endometrial cancer is eligible for treatment with the drug dostarlimab.
What will it accomplish?
The VENTANA MMR RxDx Panel helps doctors identify if patients with endometrial cancer should be considered for treatment with the drug dostarlimab based on their test results.
When should it not be used?
There are no known reasons not to use this test.
Additional information (including warnings, precautions and adverse events):
- Summary of Safety and Effectiveness Data
- PMA Database Entry
- FDA grants accelerated approval to dostarlimab-gxly for dMMR endometrial cancer