Adjuvant Enhertu gets priority

AstraZeneca and Daiichi Sankyo are edging closer to expanding Enhertu into perioperative breast cancer, after the FDA accepted a filing for the drug's use as an adjuvant therapy. The application, which has been granted priority review, is backed by results from the Destiny-Breast05 trial, which compared Enhertu against Kadcyla in high-risk HER2-positive breast patients who had previously received neoadjuvant therapy. Enhertu cut the risk of disease-free survival events by 53%, meeting the study's primary endpoint. But the trial also highlighted a familiar concern for the deruxtecan-based antibody-drug conjugate: interstitial lung disease. Two drug-related deaths linked to ILD were reported, and could carry particular significance in the adjuvant setting, where patients may remain on therapy for long periods of time. As in previous regulatory milestones for the drug, Daiichi Sankyo disclosed the exact PDUFA date for the application: 7 July 2026. As such, a decision could come almost two months later than the PDUFA date for the filing seeking approval for the drug's neoadjuvant use in HER2-positive breast cancer, based on results from the Destiny-Breast11 study.

Enhertu's pivotal trials in perioperative HER2-positive breast cancer

Source: OncologyPipeline.