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Daiichi Sankyo and AstraZeneca Report the US FDA Acceptance of sBLA and Granted Priority Review of Enhertu for HER2 Low Metastatic Breast Cancer

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Daiichi Sankyo and AstraZeneca Report the US FDA Acceptance of sBLA and Granted Priority Review of Enhertu for HER2 Low Metastatic Breast Cancer

Daiichi Sankyo and AstraZeneca Report the US FDA Acceptance of sBLA and Granted Priority Review of Enhertu for HER2 Low Metastatic Breast Cancer

Shots:

  • The sBLA was based on the P-III (DESTINY-Breast04) trial evaluating Enhertu (5.4mg/kg) vs CT in a ratio (2:1) in 557 patients with HR+ or HR-, HER2 low unresectable or metastatic breast cancer at multiple sites in Asia, EU & North America. The US FDA’s decision is expected in Q4'22
  • The therapy sowed superior clinical efficacy in PFS & OS. The safety profile was consistent with prior trials with no new safety concerns. The results were presented at ASCO 2022 & published in NEJM
  • The application is being reviewed under the US FDA's RTOR program & Project Orbis for cancer patients shortly. Enhertu (6.4mg/kg) was approved in multiple countries for LA or metastatic HER2+ gastric or GEJ adenocarcinoma

Ref: Bussinesswire | Image: Daiichi Sankyo

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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