AstraZeneca Shares Edge Higher After Drug Approvals

AstraZeneca announced on Tuesday that the FDA approved Enhertu in combination with pertuzumab for first-line HER2-positive metastatic breast cancer, and that the European Commission approved Saphnelo for subcutaneous self-administration in systemic lupus erythematosus (SLE).

The FDA's decision to approve Enhertu plus pertuzumab is based on the DESTINY-Breast09 Phase III trial results, which demonstrated a 44% reduction in the risk of disease progression or death compared to the current standard regimen.

Median progression-free survival (PFS) extended to an impressive 40.7 months versus 26.9 months with the traditional taxane, trastuzumab, and pertuzumab (THP) treatment. This approval fills a decade-long void in new first-line treatments for this aggressive form of breast cancer, potentially establishing Enhertu as the new standard of care.

Following the U.S. approval of Enhertu, AstraZeneca is obligated to make a $150 million milestone payment to Daiichi Sankyo, reflecting the collaborative nature of the drug's development and commercialization. Notably, U.S. sales of Enhertu are recognized by Daiichi Sankyo.

In parallel, the European Commission's approval of Saphnelo for subcutaneous self-administration offers a more convenient treatment option for SLE patients.

The approval is rooted in the Phase III TULIP-SC trial, which showcased a statistically significant and clinically meaningful reduction in disease activity compared to placebo. With approximately 70% of European patients on biologics preferring subcutaneous self-administration, this approval broadens Saphnelo's market reach and provides patients with greater flexibility in managing their condition.