FDA Approves Enhertu and Perjeta Combination for First-Line HER2-Positive Breast Cancer Treatment

The FDA has granted approval for Enhertu, in combination with Roche’s Perjeta, as a first-line treatment for patients with unresectable or metastatic HER2-positive breast cancer. This decision follows the results of a late-stage clinical trial that demonstrated a 44% reduction in the risk of disease progression or death when compared to standard treatment options.

This approval marks a significant advancement in the therapeutic landscape for HER2-positive breast cancer, a subtype known for its aggressive nature and limited treatment options. The combination therapy not only enhances the efficacy of existing treatments but also underscores the ongoing collaboration between AstraZeneca and Daiichi Sankyo, which could lead to further innovations in oncology. As the market adapts to this new standard of care, stakeholders in regulatory, QA/QC, and sourcing sectors must prepare for the implications on drug availability and patient access.