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FDA Approves Enhertu and Pertuzumab Combination for First-Line Treatment of Specific Breast Cancers

The approval highlights the effectiveness of a new combination therapy in extending progression-free...
Key Metrics

10.4

Heat Index
  • Impact Level
    Medium
  • Scope Level
    National
  • Last Update
    2025-12-16
Key Impacts
Positive Impacts (7)
AstraZeneca PLC
Daiichi Sankyo Co., Ltd.
Roche Holding AG
Nasdaq Biotechnology Index (NBI)
Agilent Technologies (Dako HER2 test kits)
Healthcare Cost Inflation Expectations
Negative Impacts (1)
Seagen / Pfizer (Tukysa franchise)
Total impacts: 11 | Positive: 7 | Negative: 1
Event Overview

The approval highlights the effectiveness of a new combination therapy in extending progression-free survival. This regulatory decision is based on clinical trial data, demonstrating significant improvement over the standard treatment regimen.

Collect Records
FDA Approves Combination of Enhertu and Pertuzumab for First-Line Treatment of Certain Breast Cancers
2025-12-16 23:59

The FDA has approved the combination of fam-trastuzumab deruxtecan (Enhertu) from AstraZeneca and Daiichi Sankyo, with pertuzumab, for first-line treatment of certain breast cancers. This approval is based on the DESTINY-Breast09 trial, which showed a median progression-free survival (PFS) of 40.7 months, compared to 26.9 months for the standard THP regimen. Pertuzumab is marketed by Roche.

Total records: 1
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