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Agilent's Dako Lands FDA Approval for Lung Cancer Complementary Dx

NEW YORK (GenomeWeb) – Agilent Technologies today announced its subsidiary Dako has received US Food and Drug Administration approval for a complementary diagnostic for Bristol-Myers Squibb's non-squamous non-small cell lung cancer (NSCLC) drug Opdivo (nivolumab).

The complementary diagnostic, PD-L1 IHC 28-8 pharmDx, identifies PD-L1 expression levels on the surface of NSCLC cells and provides information on the survival benefit of treatment with Opdivo.

At a recent conference in Washington, DC, the agency discussed its thinking around complementary diagnostics. This kind of complementary test, according to the agency, may be used to define a subset of patients that respond particularly well to a drug and aid in risk/benefit assessments, but unlike a companion diagnostic, the test isn't a prerequisite for receiving the drug.

PD-L1 testing is not required for the use of Opdivo, but it may provide additional information for physicians and inform patient dialogue, the FDA said in a statement.

The firm also said that the FDA today expanded the indication for Opdivo to include previously treated non-squamous NSCLC in addition to the squamous NSCLC indication.

Dako began working on the complementary diagnostic in partnership with Japanese firm Ono Pharmaceutical in February. Bristol-Meyers Squibb holds global development and commercialization rights to Opdivo outside of Japan, South Korea, and Taiwan.

Last week, Dako announced that the FDA had approved its PD-L1 IHC 22C3 pharmDx test as a  companion diagnostic alongside Merck's anti-PD-1 therapy Keytruda (pembrolizumab).


This article has been updated from an earlier version to correctly state that the FDA approved a complementary diagnostic, not a companion diagnostic, for Opdivo.

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