The treatment of human epidermal growth factor receptor 2-positive (HER2+) breast cancer is characterised by a moderate level of unmet clinical need. It was one of the first oncology indications to benefit from the development of targeted therapies, in the form of Herceptin (trastuzumab), which was first approved by the US Food and Drug Administration (FDA) in 1998. With the introduction of Herceptin in both earlier and advanced settings, in addition to the introduction of effective antibody-drug conjugates, the treatment paradigm and the subsequent improvements in patient survival have positively deviated from other underserved oncology indications.

Key opinion leaders (KOLs) interviewed by GlobalData highlight that while there is still a need for improved treatment options, in particular curative interventions and treatments for patients with brain metastases, there is also an emphasis on patient quality of life. Other notable unmet needs include the need to stratify patients by specific molecular profile and how to effectively treat intratumour heterogeneity. Label expansions for agents such as Tukysa (tucatinib) and Enhertu (trastuzumab deruxtecan), along with the approval of agents such as trastuzumab duocarmazine, are positioned to partially counter some of the unmet needs in this space. The unmet needs and opportunities in the HER2+ space are highlighted below.