Enhertu (trastuzumab deruxtecan): valutazione positiva del PRAC BCa HER2-low & HR+

Nell'agenda del PRAC (Pharmacovigilance Risk Assessment Committee) del Meeting del 29 Agosto - 1° Settembre è presente un aggiornamento in merito alla sottomissione di una variazione line-extension (EMEA/H/C/005124/II/0022) che è stata raccomandato al CHMP per adozione.

Scope: Extension of indication to include treatment of unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or withing 6 months of completing adjuvant chemotherapy. Patients with hormone receptor positive (HR+) breast cancer must additionally have received or be ineligible for endocrine therapy;for ENHERTU, based on final results from study DS8201-A-U303 (DESTINY-Breast04). This is a phase III, multicentre, randomised, open-label, active-controlled trial of Trastuzumab Deruxtecan (T-DXd), an Anti-HER2-antibody Drug Conjugate (ADC), versus treatment of physician’s choice for HER2-low, unresectable and/or metastatic breast cancer subjects. As a consequence, sections 4.1, 4.2, 4.4, 4.8, 5.1 and 5.2 of the SmPC are updated. The package leaflet and the RMP (version 1.4) are updated accordingly.

In addition, the Marketing authorisation holder (MAH) took the opportunity to update section 4.4 of the SmPC to update the dosing recommendation for corticosteroid treatment (e.g. prednisolone) with a daily dose.