ENHERTU Plus Pertuzumab Granted U.S. Breakthrough Therapy Status for HER2+ Metastatic Breast Cancer

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to ENHERTU (fam-trastuzumab deruxtecan-nxki) in combination with pertuzumab for the first-line treatment of adults with unresectable or metastatic HER2-positive breast cancer, Daiichi Sankyo and AstraZeneca announced today.

ENHERTU, a HER2-directed antibody-drug conjugate (ADC), was jointly developed by Daiichi Sankyo and AstraZeneca. The new BTD marks the ninth for ENHERTU and the fifth specifically for metastatic breast cancer, reinforcing its growing role in addressing various HER2-related cancers.

The FDA’s decision was based on positive data from the Phase 3 DESTINY-Breast09 trial, which was presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. The trial demonstrated a median progression-free survival of more than three years for patients treated with ENHERTU plus pertuzumab, a notable improvement over the current standard of care that has remained largely unchanged for more than a decade.

“This Breakthrough Therapy Designation highlights the significant potential of ENHERTU in combination with pertuzumab to transform first-line treatment for HER2-positive metastatic breast cancer,” said Dr. Ken Takeshita, Global Head of R&D at Daiichi Sankyo. “The DESTINY-Breast09 data show meaningful improvement in patient outcomes, offering new hope in a setting where innovation has long been needed.”

Breakthrough Therapy Designation is intended to expedite the development and regulatory review of promising therapies for serious or life-threatening conditions with substantial unmet need. ENHERTU’s expanding BTD portfolio spans multiple cancer types, including breast, lung, colorectal, gastric, and other HER2-positive solid tumors.