Menu
Microsoft strongly encourages users to switch to a different browser than Internet Explorer as it no longer meets modern web and security standards. Therefore we cannot guarantee that our site fully works in Internet Explorer. You can use Chrome or Firefox instead.

Agilent PD-L1 Assay Receives FDA Approval for Use as a Companion Diagnostic


Agilent Technologies Inc. (NYSE: A) today announced that the U.S. Food and Drug Administration has approved the company’s PD-L1 IHC 28-8 pharmDx for expanded use in non-small cell lung cancer (NSCLC).

Now, physicians will be able to use the PD-L1 IHC 28-8 pharmDx assay as an aid in identifying patients with metastatic NSCLC for treatment with the dual immunotherapy combination of Opdivo (nivolumab) and Yervoy (ipilimumab), manufactured by Bristol Myers Squibb. Based on the results of the Phase 3 CheckMate -227 clinical trial, Opdivo in combination with Yervoy was approved as first-line treatment for patients with metastatic NSCLC whose tumors express PD-L1 (≥1%) as determined by an FDA-approved test.

“The expanded use of PD-L1 IHC 28-8 pharmDx will give physicians in the USA critical information to inform first-line treatment decisions for patients with metastatic non-small cell lung cancer,” said Sam Raha, president of Agilent's Diagnostics and Genomics Group.

Agilent developed PD-L1 IHC 28-8 pharmDx in 2016 through a collaboration with Bristol Myers Squibb, and it has been previously approved as a complementary in vitro diagnostic for non-squamous non-small cell lung cancer, as well as other forms of cancer, including, squamous cell carcinoma of the head and neck, and urothelial carcinoma.

Lung cancer is the most commonly diagnosed cancer worldwide across both sexes, causing 18.4% of all cancer deaths, with an estimated two million new cases reported in 2018. NSCLC accounts for 80%–90% of lung cancers, and 75% of NSCLC patients are diagnosed in the advanced stage.

Agilent is a worldwide leader in the development and commercialization of precision medicine diagnostics in collaboration with biopharmaceutical companies.

Opdivo® and Yervoy® are registered trademarks of Bristol-Myers Squibb Company.

About Agilent Technologies

Agilent Technologies Inc. (NYSE: A) is a global leader in life sciences, diagnostics, and applied chemical markets. Now in its 20th year as an independent company delivering insight and innovation toward improving the quality of life, Agilent instruments, software, services, solutions, and people provide trusted answers to customers' most challenging questions. The company generated revenue of $5.16 billion in fiscal 2019 and employs 16,300 people worldwide. Information about Agilent is available at www.agilent.com. To receive the latest Agilent news, subscribe to the Agilent Newsroom. Follow Agilent on LinkedIn, Twitter, and Facebook.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200518005141/en/

Agilent Technologies Inc. Stock

€139.04
3.610%
A very strong showing by Agilent Technologies Inc. today, with an increase of €4.84 (3.610%) compared to yesterday's price.
Our community is currently high on Agilent Technologies Inc. with 17 Buy predictions and 3 Sell predictions.
On the other hand, the target price of 134 € is below the current price of 139.04 € for Agilent Technologies Inc., so the potential is actually -3.62%.
Like: 0
Share
Business Wire, a Berkshire Hathaway company, is the global leader in press release distribution and regulatory disclosure. Investor relations, public relations, public policy and marketing professionals rely on Business Wire for secure and accurate distribution of market-moving news and multimedia.

Legal notice

Comments