Skip to main content
Premium Trial:

Request an Annual Quote

Guardant Health, Daiichi Sankyo to Develop CDx for HER-2 NSCLC Drug

NEW YORK – Guardant Health said Tuesday that it has entered a strategic collaboration with Daiichi Sankyo to pursue regulatory approval of its Guardant360 CDx assay as a companion diagnostic for the pharma firm's HER-2 antibody-drug conjugate, fam-trastuzumab deruxtecan-nxki (Enhertu), for the treatment of patients with advanced metastatic non-small cell lung cancer.

Financial terms of the agreement were not disclosed.

Guardant360 CDx is already approved by the US Food and Drug Administration to provide comprehensive genomic profiling to guide treatment in all solid tumors, including NSCLC. It also has specific companion diagnostic approval to identify non-small cell lung cancer patients who may benefit from treatment with osimertinib (AstraZeneca's Tagrisso).

In a statement, Guardant CEO Helmy Eltoukhy said that the emergence of molecularly targeted cancer drugs, as well as tests like Guardant360 that identify the patients eligible for them, has already been "life-changing" for NSCLC patients with NSCLC, but therapies like Daiichi Sankyo's can address "an unmet medical need to help non-small cell lung cancer patients with HER2 mutations."

The Scan

Positive Framing of Genetic Studies Can Spark Mistrust Among Underrepresented Groups

Researchers in Human Genetics and Genomics Advances report that how researchers describe genomic studies may alienate potential participants.

Small Study of Gene Editing to Treat Sickle Cell Disease

In a Novartis-sponsored study in the New England Journal of Medicine, researchers found that a CRISPR-Cas9-based treatment targeting promoters of genes encoding fetal hemoglobin could reduce disease symptoms.

Gut Microbiome Changes Appear in Infants Before They Develop Eczema, Study Finds

Researchers report in mSystems that infants experienced an enrichment in Clostridium sensu stricto 1 and Finegoldia and a depletion of Bacteroides before developing eczema.

Acute Myeloid Leukemia Treatment Specificity Enhanced With Stem Cell Editing

A study in Nature suggests epitope editing in donor stem cells prior to bone marrow transplants can stave off toxicity when targeting acute myeloid leukemia with immunotherapy.