FDA nod for first targeted therapy for HER2-Low breast cancer

The US Food and Drug Administration (FDA) said on Friday it has approved Enhertu (fam-trastuzumab-deruxtecan-nxki), an IV infusion for the treatment of patients with unresectable (unable to be removed) or metastatic (spread to other parts of the body) HER2-low breast cancer. This is the first approved therapy targeted to patients with the HER2-low breast cancer subtype, which is a newly defined subset of HER2-negative breast cancer, the agency noted.

The FDA granted the approval of Enhertu to Japan’s Daiichi Sankyo (TYO: 4568) four months ahead of the Prescription Drug User Fee Act (PDUFA) deadline. The drug is being jointly developed and commercialized by AstraZeneca (LSE: AZN) and Daiichi Sankyo. Enhertu is forecast by some analysts to have the potential for peak sales of $7 billion.

The US regulatory submission for DESTINY-Breast04 was reviewed under Project Orbis, which provides a framework for concurrent submission and review of oncology medicines among participating international partners. As part of Project Orbis, Enhertu is also under regulatory review for the same indication by the Australian Therapeutic Goods Administration, the Brazilian Health Regulatory Agency (ANVISA), Health Canada and Switzerland’s Swissmedic.