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Agilent Technologies Inc.. (10/24/16). "Press Release: Agilent Technologies Receives Expanded FDA Approval for Use of Dako PD-L1 IHC 22C3 pharmDx Companion Diagnostic in Non-Small Cell Lung Cancer (NSCLC)". Carpinteria, CA.

Region Region United States (USA)
Organisation Organisation FDA (US Food and Drug Administration)
  Group United States (govt)
Product Product PD-L1 IHC 22-C3 pharmDx (Dako)
Persons Person Thaysen, Jacob (Agilent 201804 SVP + President LSAG business before DGG business joined via Dako acquisition)
  Person 2 Wadsworth-Hansen, Victoria (Agilent 201506 Director Global Business Public Relations)

Untreated metastatic NSCLC patients with high PD-L1 expression can now be identified for treatment with KEYTRUDA® (pembrolizumab) using PD-L1 IHC 22C3 pharmDx

In addition, the labeling update identifies a broader range of previously treated metastatic NSCLC patients with PD-L1 expression for treatment with KEYTRUDA

Agilent Technologies Inc. (NYSE: A) today announced that its Dako PD-L1 IHC 22C3 pharmDx now has an expanded label approved by the U.S. Food and Drug Administration for use in determining PD-L1 expression status to inform treatment in metastatic non-small cell lung cancer (NSCLC) with KEYTRUDA® (pembrolizumab). This expanded intended use now allows the PD-L1 IHC 22C3 pharmDx test to detect PD-L1 expression in a broader range of patients — those with a PD-L1 tumor proportion score (TPS) of 1 percent or more.

The FDA also announced on October 24 that KEYTRUDA is now approved for the first-line treatment of metastatic NSCLC patients whose tumors express high levels of PD-L1 (TPS of 50 percent or more) or for previously treated metastatic NSCLC patients whose tumors express PD-L1 (TPS of 1 percent or more).

This updated approval of PD-L1 IHC 22C3 pharmDx means that the assay can be used to identify previously untreated patients with metastatic NSCLC expressing high levels of PD-L1 for treatment with KEYTRUDA. Prior to this, chemotherapy was the standard first-line treatment for most NSCLC patients. The labeling update also means that more patients in the second-line or later treatment setting — including patients with levels of PD-L1 expression of 1 percent or more — can also be identified for treatment with KEYTRUDA.

"This expanded intended use for our FDA-approved PD-L1 IHC 22C3 pharmDx assay is a step towards providing first-line metastatic NSCLC patients with immunotherapy as an option. PD-L1 IHC 22C3 pharmDx allows pathologists to confidently determine, and report PD-L1 expression status for a patient's tumor. This critical diagnostic information informs oncologists' treatment decisions around KEYTRUDA," said Jacob Thaysen, president of Agilent's Diagnostics and Genomics Group. "Pathologists recognize the need for approved and validated tests, and our companion diagnostic gives them a highly accurate tool to inform oncologists on PD-L1 expression."

"PD-L1 is an important biomarker for use in identifying those patients with metastatic non-small cell lung cancer who are most likely to benefit from treatment with KEYTRUDA," said Dr. Roger Dansey, senior vice president and therapeutic area head, oncology late-stage development, Merck Research Laboratories. "With the approval of both the medicine and companion diagnostic to include first-line evaluation and treatment, and the broadening of the Dako PD-L1 IHC 22C3 pharmDx label in the second-line and later treatment setting, we now have the opportunity to help many more patients with this devastating disease."

Lung cancer is the leading cause of cancer-related death worldwide, and NSCLC accounts for 80 percent of all lung cancers.

PD-L1 IHC 22C3 pharmDx was developed in partnership with Merck & Co., Inc. (known as MSD outside the U.S. and Canada), maker of the anti-PD-1 therapy, KEYTRUDA.

KEYTRUDA is a humanized monoclonal antibody that works by increasing the ability of the body's immune system to help detect and fight tumor cells. KEYTRUDA blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

About Agilent Technologies and Dako

Agilent Technologies Inc. (NYSE: A), a global leader in life sciences, diagnostics and applied chemical markets, is the premier laboratory partner for a better world. Agilent works with customers in more than 100 countries, providing instruments, software, services and consumables for the entire laboratory workflow. The company generated revenues of $4.04 billion in fiscal 2015 and employs about 12,000 people worldwide.

In 2012, Agilent acquired Dako, a well-known provider of reagents, instruments, software and expertise. Agilent's Dako pathology solutions help pathologists make accurate diagnoses and determine the most effective treatment for cancer patients.

Information about Agilent is available at, and information about Agilent's Dako pathology solutions products is available here.

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Victoria Wadsworth-Hansen
Agilent Technologies, Inc.
+1 408 553 2005
+45 2933 6980

Record changed: 2016-11-04


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