FDA Approves Fam-trastuzumab Deruxtecan-nxki With Pertuzumab for Unresectable or Metastatic HER2-positive Breast Cancer

On December 15, the FDA approved fam-trastuzumab deruxtecan-nxki in combination with pertuzumab for the first-line treatment of adults with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer as determined by an FDA-approved test.

For more information, read the FDA announcement and the AstraZeneca press release.

Posted on 12/18/2025