EMA Begins Review of Enhertu Combination for First-Line Breast Cancer Therapy

2026-01-19 biotech

Amsterdam, Monday 19 January 2026
The EMA has initiated a review of Enhertu with pertuzumab for first-line HER2-positive breast cancer, potentially updating a standard of care that has remained unchanged for over a decade.

Regulatory Milestone for Advanced Therapy

The European Medicines Agency (EMA) has officially validated the Type II Variation marketing authorisation application for Enhertu (trastuzumab deruxtecan) in combination with pertuzumab, a development confirmed on 18 January 2026 [3]. This validation marks the formal commencement of the scientific review process by the EMA’s Committee for Medicinal Products for Human Use (CHMP) [1]. The application specifically seeks approval for the use of this regimen as a first-line treatment for adult patients with unresectable or metastatic HER2-positive breast cancer [3]. This regulatory step is critical as it potentially opens the door to a new therapeutic option in a clinical setting where the standard of care has remained static for more than a decade [3].

Redefining the Standard of Care

The submission is substantiated by data from the DESTINY-Breast09 Phase 3 trial, which was presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and published in The New England Journal of Medicine [1]. The trial results demonstrated that Enhertu, when combined with pertuzumab, achieved a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to the current standard regimen of taxane, trastuzumab, and pertuzumab (THP) [1][4]. The trial enrolled 1,157 patients across multiple regions, including Europe, Asia, and the Americas, randomising them to receive Enhertu monotherapy, Enhertu with pertuzumab, or the THP control arm [3].

Market Expansion and Clinical Context

This regulatory progress occurs against the backdrop of a rapidly expanding global market for antibody-drug conjugates. The sector is currently valued at USD 12.26 billion in 2024 and is projected to surge to USD 32.11 billion by 2033 [5]. This trajectory represents a total market growth of approximately 161.909 per cent over the forecast period, driven largely by the rising incidence of cancer and the increasing demand for targeted therapies [5]. In 2022 alone, over two million breast cancer cases were diagnosed globally, resulting in more than 665,000 deaths [3]. In Europe, the disease burden remains high, with approximately 557,000 annual diagnoses [3].

Sources & Ecosystem Partners

Oncology Regulatory approval