Daiichi Sankyo’s Enhertu plus pertuzumab wins EU CHMP backing for first-line HER2+ metastatic breast cancer
XLV•EU regulator backs Enhertu combination for first-line use
EU drug regulator’s CHMP backed Enhertu with pertuzumab for first-line HER2-positive metastatic breast cancer, clearing the file for European Commission review.
The recommendation followed DESTINY-Breast09 data showing a 44% lower risk of progression or death versus THP; median PFS was 40.7 months versus 26.9 months.
If cleared, the regimen would be the first new EU first-line option in more than a decade for this setting.
