Guardant Health's test gets FDA win for companion diagnostic to Enhertu's expanded use in lung cancer

Aug. 12, 2022 8:43 AM ETGuardant Health, Inc. (GH), DSKYF, AZN, DSNKYBy: Ravikash, SA News Editor

Headquarters of US Food and Drug Administration (FDA)


  • 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.

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