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Roche’s CDx Test Receives the US FDA’s Approval for HER2 Low Metastatic Breast Cancer

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Roche’s CDx Test Receives the US FDA’s Approval for HER2 Low Metastatic Breast Cancer

Roche’s CDx Test Receives the US FDA’s Approval for HER2 Low Metastatic Breast Cancer

Shots:

  • The US FDA has approved the PATHWAY anti-HER2/neu (4B5) Rabbit monoclonal primary Ab as CDx to identify patients with mBC with low HER2 expression who may be eligible for Enhertu
  • The test can be used to standardize immuno-histochemistry (IHC) processes & decrease human error in the laboratory setting. It also includes an algorithm that allows pathologists to score HER2 expression & identify the low expression
  • Enhertu will be commercialized by AstraZeneca & Daiichi Sankyo, based on the results of the P-III (DESTINY-Breast04) trial. The results showed a 50% reduction in risk of disease recurrence or death and an overall gain of 6mos. over SoC in low-expression HER2 patients treated with Enhertu

Ref: Roche | Image: Roche

Click here to­ read the full press release 

Neha

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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