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# Enhertu Given Breakthrough Status in Breast Cancer
- URL: https://www.fdaweb.com/enhertu-given-breakthrough-status-in-breast-cancer/
- Published: 2024-08-19T12:00:00.000Z
- Updated: 2026-09-14T14:38:50.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157602

FDA has granted Daiichi Sankyo and AstraZeneca a breakthrough therapy designation for Enhertu (fam-trastuzumab deruxtecan-nxki) for treating unresectable or metastatic hormone receptor-positive HER2 low or HER2 ultralow breast cancer patients who have received either two lines of endocrine therapy in the metastatic setting, or one line of endocrine therapy if they had demonstrated disease progression within six months of starting first-line treatment. The designation was based on data from the [DESTINY-Breast06](https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT04494425&esheet=54110532&newsitemid=20240818195338&lan=en-US&anchor=DESTINY-Breast06&index=1&md5=b4091de7cfd27321a363895366e06bdb&ref=fdaweb.com) Phase 3 trial [presented](https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.daiichisankyo.com%2Ffiles%2Fnews%2Fpressrelease%2Fpdf%2F202406%2F20240602%5FE2.pdf&esheet=54110532&newsitemid=20240818195338&lan=en-US&anchor=presented&index=2&md5=a87b57671d16a3b97dfeb4c66680c024&ref=fdaweb.com) at the 2024 American Society of Clinical Oncology annual meeting.

The trial data showed that Enhertu reduced the risk of disease progression or death by 38% versus chemotherapy, according to the companies. Median progression-free survival was 13.2 months in the Enhertu arm compared to 8.1 months in the chemotherapy arm.

If approved, the companies say Enhertu could “change the treatment paradigm for certain patients with breast cancer, pushing past old boundaries and broadening the number of people who may be eligible for a HER2-directed therapy.”