Daiichi Sankyo’s Enhertu secured U.S. Food and Drug Administration approval for first-line treatment of HER2-positive metastatic breast cancer, expanding the drug’s reach to patients earlier in their disease course.
The Tokyo-based drugmaker developed Enhertu and shares commercialization with partner AstraZeneca. The FDA cleared the antibody-drug conjugate for use alongside Roche’s Perjeta, based on results from the DESTINY-Breast09 trial showing the combination reduced disease progression risk by 44% compared to the current standard regimen.
Patients receiving the Enhertu combination achieved median progression-free survival of 40.7 months versus 26.9 months with existing therapy, according to trial data presented at the American Society of Clinical Oncology annual meeting.
The approval represents a meaningful expansion for Enhertu, which generated ¥318.4 billion ($2.1 billion) in global sales during the first half of fiscal 2025 and has become Daiichi Sankyo’s primary growth driver. The drug originally entered the U.S. market in late 2019 for third-line breast cancer treatment.
Whether the first-line indication translates to substantially higher revenues remains uncertain, as the competitive oncology landscape continues to intensify. Daiichi Sankyo shares commercialization profits with AstraZeneca outside Japan, limiting the Japanese company’s upside from expanded indications.
The FDA completed its review under the Real-Time Oncology Review program.
