The Chinese National Medical Products Administration has granted approval for AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) as a monotherapy to treat breast cancer. 

An antibody-drug conjugate (ADC) targeting the HER2 protein, Enhertu is indicated for use in adults with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer.

These patients should have received a previous systemic treatment in the metastatic setting, or have experienced a recurrence of the condition during or within six months of receiving adjuvant chemotherapy.

The latest approval is based on data from Phase III DESTINY-Breast04 clinical trial.

Trial data showed that the therapy reduced disease progression or the risk of death by half, and boosted median overall survival by more than six months compared with physician’s choice of chemotherapy.

In February 2023, the ADC was approved for treating priorly treated unresectable or metastatic HER2-positive breast cancer

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AstraZeneca oncology business unit executive vice-president Dave Fredrickson stated: “The results from the DESTINY-Breast04 trial show Enhertu provides a significant improvement in outcomes compared to chemotherapy for patients whose tumours are determined to be HER2-low via routine testing. 

“This approval is an important advance in the way breast cancer is classified and treated in China and supports our vision to bring Enhertu to more patients worldwide.”