September 2023 Pharma News Vanessa Vernimmen

Since July 1st 2023, trastuzumab deruxtecan is reimbursed in monotherapy for adult patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2-based regimens. Patients must have received previous treatment with trastuzumab and a taxane.1 Reimbursement was based on the results of the DESTINY-Breast03 trial in which trastuzumab deruxtecan (T-DXd) demonstrated a median progression-free survival by blinded independent central review of 28.8 months, as compared to 6.8 months with trastuzumab emtansine (T-DM1, p< 0.0001). In addition, T-DXd showed a significant improvement in overall survival versus T-DM1 in patients with HER2-positive metastatic breast cancer (HR[95%CI]: 0.64[0.47-0.87], p= 0.0037).2 A consistent benefit in median PFS was observed in all prespecified subgroups treated with T-DXd, including patients with stable brain metastases, patients with visceral disease, and patients with prior pertuzumab treatment.3 Belgian clinical practice guidelines for the treatment of patients with HER2-positive advanced breast cancer state that T-DXd should be considered the preferred second-line therapy in most clinical scenarios.4


  1. Summary of product characteristics ENHERTU®
  2. Hurvitz S, et al. Lancet 2023;401:105-17.
  3. Cortes J, et al. N Engl J Med. 2022;386:1143-54.
  4. Nader-Marta G, et al. Belg J Med Oncol. 2022;16(6):287-92.