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# FDA OKs Enhertu Combo as First-Line for Advanced Breast Cancer
- URL: https://www.fdaweb.com/fda-oks-enhertu-combo-as-first-line-for-advanced-breast-cancer/
- Published: 2025-12-15T12:00:00.000Z
- Updated: 2026-09-14T15:29:10.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160388

FDA has approved Daiichi Sankyo’s Enhertu (fam-trastuzumab deruxtecan-nxki) in combination with Genentech’s pertuzumab as a first-line treatment for adults with unresectable or metastatic HER2-positive breast cancer, expanding treatment options for patients with advanced disease. The approval covers patients whose tumors are HER2-positive — defined as immunohistochemistry 3+ or *in situ* hybridization+ — as determined by an FDA-approved test.

The decision is based on data from the Phase 3 DESTINY-Breast09 trial, a randomized, three-arm, global study involving 1,157 adults with advanced or metastatic HER2-positive breast cancer who had not previously received chemotherapy or HER2-targeted therapy for metastatic disease, or whose prior adjuvant or neoadjuvant HER2 therapy occurred more than six months earlier, according to an [FDA release](https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-fam-trastuzumab-deruxtecan-nxki-pertuzumab-unresectable-or-metastatic-her2-positive?utm%5Fmedium=email&utm%5Fsource=govdelivery). Patients were assigned to receive Enhertu plus pertuzumab, a standard regimen of taxane chemotherapy with trastuzumab and pertuzumab (THP), or an investigational therapy.

Patients treated with the Enhertu–pertuzumab combination demonstrated a statistically significant improvement in progression-free survival compared with those receiving THP, FDA says. Median progression-free survival reached 40.7 months in the Enhertu combination arm, versus 26.9 months in the THP arm, representing a 44% reduction in the risk of disease progression or death. Confirmed objective response rates were also higher with the Enhertu combination, at 87%, compared with 81% for the standard regimen.