Shots:
- The EMA has validated the Type II Variation MAA for Enhertu as a monotx. for the treatment of adults with HER2+ (IHC 3+ or ISH+) breast cancer who have residual invasive disease after neoadjuvant HER2 targeted treatment
- MAA was backed by the global P-III (DESTINY-Breast05) trial assessing Enhertu (5.4mg/kg) vs trastuzumab emtansine in 1,635 HER2+ primary breast cancer pts, which showed improved invasive disease-free survival (1EP)
- Additional EU regulatory filings are underway for Enhertu, incl. its combination with Perjeta for 1L treatment of unresectable or metastatic HER2+ breast cancer based on DESTINY-Breast09, & for previously treated HER2+ unresectable or metastatic solid tumors supported by DESTINY-PanTumor02, DESTINY-CRC02, & DESTINY-Lung01
Ref: Businesswire | Image: Daiichi Sankyo | Press Release
Related News: Daiichi Sankyo Reports First Patient Dosing in P-I/II Trial of DS3790 for R/R B-Cell Non-Hodgkin Lymphoma
PharmaShots, your go-to media platform for customized news ranging across multiple indications. For more information, connect with us at connect@pharmashots.com
