On 8 May 2025, AstraZeneca announced that India’s Central Drugs Standard Control Organisation (CDSCO) has approved an indication extension for Enhertu® (trastuzumab deruxtecan) in 100 mg solution for infusion as monotherapy for the treatment of adult patients with unresectable or metastatic HER2- low or HER2- ultralow breast cancer, who have previously received at least one endocrine therapy in metastatic setting.
The same indication was approved by the US FDA in January 2025, following the grant of priority review in October 2024.
Enhertu® has recently been considered for reimbursement by Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) at its May 2025 meeting – the outcomes are yet to be published. In December 2024, New Zealand’s Pharmac announced additional funding for Enhertu® for people with HER2-positive metastatic breast cancer.