Dako, an Agilent Technologies company and a worldwide provider of cancer diagnostics, today announced that the U.S. Food and Drug Administration (FDA) has approved the expansion of the intended use of Dako PD-L1 IHC 28-8 pharmDx to include patients with melanoma.
Dako's PD-L1 IHC 28-8 pharmDx diagnostic first received approval from the FDA on Oct. 9, 2015, for non-squamous, non-small cell lung cancer (NSCLC). The complementary test has now been expanded to include melanoma and may be used by physicians to determine PD-L1 status. Positive PD-L1 status in melanoma has been correlated with the magnitude of treatment effect on progression-free survival from OPDIVO® (nivolumab), from Bristol-Myers Squibb. These complementary tests are distinct from companion diagnostics, which are essential for safe and effective use of a drug. Biomarker testing is not required for the OPDIVO + YERVOY® Regimen or OPDIVO as a single-agent, but it may provide additional information for physicians regarding the use of OPDIVO.
"We are truly excited about the FDA's approval of the PD-L1 test for use in melanoma in addition to the lung indication we received last year," said Jacob Thaysen, president of Agilent's Diagnostics and Genomics Group. "This is testimony to the extensive work that has gone into developing this highly useful test and underlines the importance of the PD-L1 marker. Agilent proves its leadership yet again in the diagnostics space, as we are the first company providing FDA-approved tests for lung cancer and melanoma for PD-L1 markers."
Dako is a worldwide leader in partnering with pharmaceutical companies to develop immunohistochemical-based diagnostics for cancer therapy.