BRIEF—Added approval for Enhertu in China

UK pharma major AstraZeneca and Japan’s Daiichi Sankyo today revealed that their Enhertu (trastuzumab deruxtecan) has been approved by China’s National Medical Products Administration (NMPA).

The authorization for Enhertu is as a monotherapy for the treatment of adult patients with 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 within six months of completing adjuvant chemotherapy.

Enhertu is a specifically engineered HER2-directed antibody drug conjugate (ADC) being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.

It follows the  approval granted by China’s NMPA for Enhertu in patients with previously treated unresectable or metastatic HER2-positive breast cancer in February 2023.