Guardant Health has been building up a solid liquid biopsy portfolio at a steady pace. The Redwood City, CA based-company expanded its arsenal last week when it won a nod from FDA to use the Guardant 360 CDx as a companion diagnostic for Janssen Pharmaceutical’s Rybrevant, metastatic non-small cell lung cancer (NSCLC).
Rybrevant won accelerated FDA approval last week. Beerse, Belgium-based Janssen said Rybrevant is the first fully-human, bispecific antibody approved for the treatment of patients with NSCLC that targets EGFR exon 20 insertion mutations, which are the third most prevalent activating EGFR mutation.
Approval of Rybrevant follows the FDA's decision to grant Breakthrough Therapy Designation (BTD) in March 2020 and to initiate a Priority Review of the Biologics License Application (BLA) in December 2020.
Guardant said the companion diagnostics nod allows the test to be used for tumor mutation profiling, or comprehensive genomic profiling, to identify patients with locally advanced or (NSCLC) who harbor the EGFR exon 20 insertion mutation and may benefit from targeted treatment with Rybrevant after progressing on or after platinum-based chemotherapy.
The company first announced the partnership with Janssen Biotech in July of 2020.
“[FDA’s] approval of Guardant360 CDx as a companion diagnostic for Rybrevant, the first targeted therapy to treat EGFR exon 20 mutations, is a key milestone for patients who, until now, have had limited treatment options,” Helmy Eltoukhy, Guardant Health CEO said in a release. “We are proud to offer our Guardant360 CDx liquid biopsy blood test as a companion diagnostic so that patients may have access to comprehensive genomic profiling in order to see if they are eligible to receive this new treatment.”
The firm hit a milestone in August of 2020 when it won a nod from FDA that made the Guardant 360 CDx the first biopsy test for comprehensive tumor mutation profiling across all solid cancers to obtain approval.