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Guardant Health Receives MHLW Approval for Guardant360 CDx as Companion Diagnostic to Enhertu for Non-Small Cell Lung Cancer

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Guardant Health Receives MHLW Approval for Guardant360 CDx as Companion Diagnostic to Enhertu for Non-Small Cell Lung Cancer

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  • The MHLW has approved the Guardant360 CDx liquid biopsy test as a companion diagnostic for Enhertu to select patients with unresectable advanced or recurrent NSCLC with HER2 (ERBB2) mutations that have progressed after CT
  • The test was also approved in the US as a CDx for the same indication; also approved by MHLW to identify patients with MSI-High solid tumors who may benefit from Keytruda; for MSI-high advanced colorectal cancer and metastatic NSCLC who may benefit from treatment with Opdivo & Lumakras
  • Guardant360 CDx test was also approved by MHLW in Mar 2022 for comprehensive genomic profiling in patients with advanced solid tumors and received national reimbursement approval in Japan in July 2023

Ref: Guardant Health | Image: Guardant Health

Related News:- Guardant Health Collaborated with AnHeart Therapeutics to Develop Guardant360 CDx and Guardant360 TissueNext for Taletrectinib 

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Senior Editor

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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