
FDA Approves Enhertu for Use in Metastatic Breast Cancer
This approval of trastuzumab deruxtecan (Enhertu) follows the March release of data from the DESTINY-Breast03 trial on the anti-HER2 monoclonal antibody, also a HER2-directed antibody-drug conjugate, which indicated superior outcomes vs trastuzumab emtansine.
Adult patients living with unresectable or metastatic HER2-positive
In 2021, breast cancer was
Now, Enhertu can be utilized as adjuvant or neoadjuvant therapy among individuals whose disease recurs within 6 months of them finishing treatment with another anti-HER2 therapy, as well as in cases of metastatic disease. The chemotherapy
“Enhertu is already established in the later-line treatment of patients with HER2-positive metastatic breast cancer, and we are thrilled that with this approval, patients in the US will now be able to access the transformative potential of Enhertu earlier in their treatment,” said Dave Fredrickson, executive vice president, Oncology Business Unit, AstraZeneca,
The approval follows
Enhertu first received
This newest approval comes via the FDA’s Real-Time Oncology Review program. The press release also noted the inclusion of Enhertu as a Category 1 recommendation in the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology for persons who have local or regional stage IV HER2-positive breast cancer.
Among the DESTINY-Breast03 findings that the FDA based its decision on are the 72% (HR, 0.28; 95% CI, 0.22-0.37; P < .0001) reduced risk of disease progression or death vs trastuzumab emtansine, as well as the lack of grade 4/5 treatment-related interstitial lung disease events.
“Today’s FDA approval highlights the importance of the FDA’s accelerated pathway that allows for earlier approval of medicines to treat serious medical conditions such as breast cancer,”
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