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 28-8 pharmDx
PMA Applicant: Dako North America, Inc.
Address: 6392 Via Real, Carpinteria, CA 93013
Approval Date: May 15, 2020
Approval Letter: Approval Order
What is it? The PD-L1 IHC 28-8 pharmDx is a lab test doctors can use to identify if patients with non-small cell lung cancer (NSCLC) have the protein called programmed cell death ligand 1 (PD-L1) in their cancer.
This lab test was previously approved to identify the PD-L1 protein in patients with non-squamous lung, urothelial, and head or neck squamous cell cancer for treatment with the drug, OPDIVO® (nivolumab). This approval expands the indications for use for this test for determining whether patients with NSCLC should be treated with the drugs, OPDIVO® (nivolumab) and YERVOY® (ipilimumab).
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? To help doctors decide whether a patient who has NSCLC is eligible for treatment with the drugs OPDIVO® and YERVOY®.
What will it accomplish? The PD-L1 IHC 28-8 pharmDx helps to determine if NSCLC patients should be treated with the drugs OPDIVO® and YERVOY®, based on their test result.
When should it not be used? There are no known reasons not to use this test.
Additional information (including warnings, precautions, and adverse events):