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: PD-L1 IHC 22C3 pharmDx
PMA Applicant: Dako North America, Inc
Address: 6392 Via Real, Carpinteria, CA 93013
Approval Date: August 16, 2018
Approval Letter: Approval Order
What is it? PD-L1 IHC 22C3 pharmDx is a laboratory test doctors can use to identify the protein programmed cell death ligand 1 (PD-L1) in tumor tissue obtained from patients who have urothelail cancer. This approval expands the indications for use for this test for determining whether patients with urothelail cancer are eligible for treatment with the medicine KEYTRUDA® (pembrolizumab).
How does it work?
- A doctor obtains a small piece of cancerous tissue from the patient's tumor and sends it to a lab.
- At the lab, the tissue sample is put into wax and a thin slice is cut off and tested with this test. If the tumor cells in the slice have PD-L1, it will react with the slice and stain the slice dark brown.
The lab clinician (pathologist) evaluates the slice under the microscope and informs the patient's doctor if PD-L1 was present.
When is it used? PD-L1 IHC 22C3 pharmDx can be used by doctors to help decide whether a patient is eligible for treatment with KEYTRUDA® (pembrolizumab). Doctors use KEYTRUDA® to treat patients who have urothelial cancer and are ineligible to receive cis-platin based chemothrapy.
What will it accomplish? The PD-L1 IHC 22C3 pharmDx helps identify patients with urothelial cancer who are eligible for treatment with KEYTRUDA®.
When should it not be used? There are no known contraindications.
Additional information (including warnings, precautions, and adverse events):