Daiichi Sankyo Reports the sNDA Submission of Enhertu to Treat HER2 Low or Ultralow Metastatic Breast Cancer in Japan
Shots:
- Daiichi Sankyo has submitted sNDA of Enhertu to the MHLW for treating HER2 low or ultralow inoperable or recurrent breast cancer. Further submissions are under review across the EU & US
- Submission was based on P-III (DESTINY-Breast06) study assessing Enhertu (5.4mg/kg) vs investigator’s choice of CT to treat HR+/HER2-low or ultralow advanced or metastatic breast cancer. Data was highlighted at ASCO 2024 & published in the NEJM
- Study demonstrated reduced risk of disease progression or death by 37% with mPFS of 13.2mos. vs 8.1mos. in the overall population. Similar results were seen in HER2-low & ultralow patients, with mPFS of 13.2mos. vs 8.1mos. & 13.2mos. vs 8.3mos., respectively
Ref: Daiichi Sankyo | Image: Daiichi Sankyo
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
