- The U.S. Food and Drug Administration (FDA) approved Guardant Health's ( NASDAQ: GH ) liquid biopsy test Guardant360 CDx as a companion diagnostic (CDx) to select patients for the new use of AstraZeneca ( NASDAQ: AZN ) and Daiichi Sankyo's ( OTCPK:DSKYF ) ( OTCPK:DSNKY ) cancer drug Enhertu.
- Guardant360 can now be used to identify patients with unresectable or metastatic HER2-mutant non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations and may benefit from treatment with Enhertu.
- Earlier in the day, British drugmaker AstraZeneca said that the FDA had approved the expanded use of Enhertu for these particular patients.
For further details see:
Guardant Health's test gets FDA win for companion diagnostic to Enhertu's expanded use in lung cancer