ENHERTU Type II Variation Application Validated by EMA for Patients with HER2 Low or Ultralow Metastatic Breast Cancer Following At Least One Endocrine Therapy

“This submission builds on our existing indication for ENHERTU in patients with HER2 low metastatic breast cancer and an expanded approval would enable the potential for use in an earlier disease setting as well as in a broader patient population that now includes HER2 ultralow,” said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. “We look forward to working closely with the EMA to potentially bring this medicine to more patients in the EU.”

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