Document › Details
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||United States (USA)|
|Organisation||FDA (US Food and Drug Administration)|
|Group||United States (govt)|
|Product||PD-L1 IHC 22-C3 pharmDx (Dako)|
|Person||Thaysen, Jacob (Agilent 201411 VP + President of DGG business unit joined Agilent via acquisition of Dako)|
|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 www.agilent.com, and information about Agilent's Dako pathology solutions products is available here.
# # #
Agilent Technologies, Inc.
+1 408 553 2005
+45 2933 6980
Record changed: 2016-11-04
More documents for Agilent (Group)
-  Agilent Technologies Inc.. (1/3/17). "Press Release: Agilent Technologies to Present at 35th Annual J.P. Morgan Healthcare Conference". Santa Clara, CA....
-  Agilent Technologies Inc.. (12/20/16). "Press Release: Agilent Technologies to Acquire Multiplicom N.V., a Leading European Diagnostics Company with State-of-the-Art Genetic Testing Technology and Products". Santa Clara, CA & Niel....
-  Agilent Technologies Inc.. (12/12/16). "Press Release: Agilent Technologies Presents Thought Leader Award to Bioengineering Researcher Rohit Bhargava of University of Illinois Cancer Center". Santa Clara, CA....
-  Agilent Technologies Inc.. (12/8/16). "Press Release: Agilent Technologies and Transcriptic Collaborate to Automate Discovery Biology". Santa Clara, CA....
-  Agilent Technologies Inc.. (11/30/16). "Press Release: Agilent Technologies Opens Folsom Technology Center. New Facility Includes Laboratory, Order Fulfillment and Warehousing Space". Santa Clara, CA....
-  Agilent Technologies Inc.. (11/28/16). "Press Release: Agilent Technologies Presents Thought Leader Award to Influential Clinical Genomics Researcher". Santa Clara, CA....
-  Agilent Technologies Inc.. (11/17/16). "Press Release: Agilent Technologies Increases Cash Dividend to 13.2 Cents per Share". Santa Clara, CA....
-  Agilent Technologies Inc.. (11/15/16). "Press Release: Agilent Technologies Reports Fourth-Quarter 2016 Results". Santa Clara, CA....
-  Agilent Technologies Inc.. (11/10/16). "Press Release: Agilent Technologies Expands Data Processing Offering for Molecular Pathology. Cartagenia Bench Addresses Inherent Challenges of Somatic Variant Assessment". Santa Clara, CA....
-  Agilent Technologies Inc.. (11/1/16). "Press Release: Agilent Technologies and PureHoney Technologies to Develop New Applications for RapidFire/MS System". Santa Clara, CA & Acton, MA....
To subscribe to our free, monthly mass spectrometry newsletter, please send an e-mail to firstname.lastname@example.org and simply fill the subject line with the word »MSC newsletter«
To get even more information, please take a look at our [gs] professional services offering and read the gene-sensor Product Flyer [PDF file]