Skip to main content
Premium Trial:

Request an Annual Quote

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.

The Scan

Steps for Quick Review

The US Food and Drug Administration is preparing for the quick review of drugs and vaccines for the Omicron variant, according to the Wall Street Journal.

Moving Away From Using Term 'Race'

A new analysis finds that geneticists are using the term "race" in their papers less than in years past, as Science reports.

Point of the Program

The Guardian writes that some scientists have called the design of a UK newborn sequencing program into question.

Science Papers Present Multi-Omic Analysis of Lung Cells, Regulation of Cardiomyocyte Proliferation

In Science this week: a multi-omic analysis of lung cells focuses on RIT1-regulated pathways, and more.