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: July 30, 2019
Approval Letter: Approval Order
What is it? The 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 esophageal squamous cell cancer.
This laboratory test was previously approved to identify the PL-L1 tumor in patients with lung, gastric, urothelial, cervical and head and neck cancer. This approval expands the indications for use for this test for determining whether patients with esophageal squamous cell cancer are eligible for treatment with the medicine KEYTRUDA® (pembrolizumab).
How does it work? The doctor sends a small piece of cancerous tissue from the patient to a lab. The lab then puts the cancerous tissue into wax and cuts a thin slice of it. The lab treats the slice with this test. If the slice has PD-L1, it will stain dark brown. The lab clinician (pathologist) looks at the slice. The lab tells the ordering doctor if PD-L1 was present in the slice and whether or not the sample is positive based on criteria that is specific for each cancer type.
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®.
What will it accomplish? The PD-L1 IHC 22C3 pharmDx helps identify patients for treatment with KEYTRUDA® based on their test result.
When should it not be used? There are no known contraindications.
Additional information (including warnings, precautions, and adverse events):