Daiichi Reports EMA’s Validation of MAA and Accelerated Assessment for Trastuzumab Deruxtecan to Treat HER2 Positive Metastatic Breast Cancer

 Daiichi Reports EMA’s Validation of MAA and Accelerated Assessment for Trastuzumab Deruxtecan to Treat HER2 Positive Metastatic Breast Cancer

Shots:

  • The MAA validation is based on P-II DESTINY-Breast01 trial assessing Trastuzumab Deruxtecan as a monothx in patients with 2L+ HER2 positive metastatic breast cancer and the results were published in the NEJM
  • The EMA’s CHMP validation provides the application is complete and commences the scientific review process while CHMP’s accelerated assessment is granted to products with public health interests and therapeutic innovation further leading reduction in approval timelines
  • Trastuzumab deruxtecan (fam-trastuzumab deruxtecan-nxki) is a HER2 directed ADC developed using Daiichi Sankyo’s DXd ADC technology approved in the US and Japan also received the US FDA’s BT designation for 2L+ HER2 positive unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma

Click here to read full press release/ article | Ref: Daiichi Sankyo | Image: Behance

Vartika Singh

Vartika Singh is a content writer who loves to write research articles and reports at PharmaShots. She has in-depth knowledge of the life sciences industry including the Pharma and Biotech sectors. Any articles written by her can be contacted at connect@pharmashots.com.

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