Agilent Technologies Inc. (NYSE: A) today announced that the U.S. Food and Drug Administration (FDA) has approved the cancer diagnostic known as PD-L1 IHC 28-8 pharmDx for use in cases of urothelial carcinoma (UC) and of squamous cell carcinoma of the head and neck (SCCHN).
The test had previously been approved for melanoma as well as non-squamous, non-small-cell lung cancer (NSCLC). PD-L1 IHC 28-8 pharmDx, developed in collaboration with Bristol-Myers Squibb (BMS), has a broad utility with more clinically validated tumor indications than any other commercially produced PD-L1 assay currently on the U.S. market.
The PDL1 IHC 28-8 pharmDx test enables physicians in the USA to identify which patients with locally advanced or metastatic UC and recurrent or metastatic SCCHN who have disease progression on or after platinum-based chemotherapy would most likely benefit from treatment with Opdivo® (nivolumab). Opdivo is an immunotherapy developed by BMS and approved in these indications regardless of PD-L1 status. While the test is not required for treatment, with these latest indications, pathologists in the USA now have access to a clinically validated complementary test to determine tumor PD-L1 status, in patients with these difficult to treat diseases.
SCCHN is the most common form of head and neck cancer. Data from a pre-specified exploratory analysis of the CHECKMATE-141 clinical trial showed that tumor PD-L1 expression, as detected by PD-L1 IHC 28-8 pharmDx in SCCHN, may be associated with an enhanced survival benefit for the patient from the use of Opdivo.
Urothelial carcinoma is the most common type of bladder cancer, accounting for approximately 90% of diagnoses1. Data from a recent clinical study CHECKMATE-275, showed that tumor PD-L1 expression assessed by PD-L1 IHC 28-8 pharmDx may help inform which UC patients are more likely to respond to Opdivo.
"I am delighted that this approval by the FDA enables our products to help inform better patient selection for these very distressing cancers," said Jacob Thaysen, president of Agilent's Diagnostics and Genomics Group. "Agilent's Dako brand of innovative pathology diagnostics seek to deliver results that pathologists can trust. Our rigorous design process ensures that evidence is based not only on analytical validation but also clinical validation by inclusion in our partner's clinical trials."
Immunotherapies are designed to help an individual's immune system detect and kill cancer cells. Because individual patients often respond differently to the same treatment, scientists have been focusing emphasis on personalized medicine, which is where Agilent's Dako brand of diagnostics comes into play, providing important information about the status of key biomarkers in individual cancer patients.
Agilent is a worldwide leader in partnering with pharmaceutical companies to develop diagnostics using both immunohistochemical and genomic-based technologies for cancer therapy.
1 Kaufman DS, Shipley W, Feldman AS. Bladder cancer. Lancet. 2009;374(9685):239-49.