Enhertu Secures 7th FDA Approval for Expanded Use in HER2-Low and HER2-Ultralow Breast Cancer

Expanded Approval:
Enhertu (fam-trastuzumab deruxtecan-nxki) has been approved by the FDA for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer, as determined by an FDA-approved test, that has progressed on one or more endocrine therapies in the metastatic setting24.

Clinical Trial Results: The approval was based on the results from the DESTINY-Breast06 Phase III trial, which showed a 36% reduction in the risk of disease progression or death versus chemotherapy (hazard ratio [HR] 0.64; 95% confidence interval [CI]:
0.54-0.76; p<0.0001) in the overall trial population of patients with chemotherapy-naïve HER2-low or HER2-ultralow metastatic breast cancer2.

Treatment Indications:
Enhertu is now indicated for a broader range of breast cancer patients, including those with HER2-ultralow expression, marking a significant expansion in its use24.

Global Availability:
Enhertu is approved in more than 65 countries worldwide for various indications in breast cancer, including HER2-positive and HER2-low breast cancer4.

Safety Profile:
The safety profile of Enhertu in DESTINY-Breast06 was consistent with previous clinical trials of Enhertu, with warnings for interstitial lung disease and embryo-fetal toxicity25.

Sources:

2. https://www.biospace.com/press-releases/enhertu-fam-trastuzumab-deruxtecan-nxki-approved-in-the-us-as-first-her2-directed-therapy-for-patients-with-her2-low-or-her2-ultralow-metastatic-breast-cancer-following-disease-progression-after-one-or-more-endocrine-therapies

4. https://www.daiichisankyo.com/files/news/pressrelease/pdf/202410/20241004_E.pdf

5. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-enhertu-fam-trastuzumab-deruxtecan-nxki-unresectable-or