Trastuzumab Deruxtecan (Enhertu) Approved in China for HER2-Positive Metastatic Breast Cancer

Intelligent Finance APP learned on February 24 that the official website of the National Medical Products Administration (NMPA) of China has recently announced that Enhertu (generic name: Trastuzumab Deruxtecan), an injectable drug jointly developed by AstraZeneca (AZN.US) and Daiichi Sankyo, has been officially approved for marketing in China. Public information shows that Enhertu (English trade name: Enhertu, generic name: Trastuzumab Deruxtecan) is an antibody-drug conjugate (ADC) targeting HER2, which has been approved for various indications overseas. This is the first approval of the drug in China, for the indication: monotherapy for adult patients with unresectable or metastatic HER2-positive breast cancer who have previously received one or more anti-HER2 drug treatments.

Public information shows that Trastuzumab Deruxtecan is composed of a humanized monoclonal antibody targeting HER2, connected to a topoisomerase I inhibitor payload via a cleavable tetrapeptide linker. The mechanism of action of this drug is: first, the antibody portion in the drug targets and attaches to HER2 on cancer cells; then Trastuzumab Deruxtecan enters the cancer cell and releases the chemotherapy drug, where the chemotherapy portion of the ADC can kill cancer cells as well as nearby other cells.

On April 12, 2022, the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) designated trastuzumab deruxtecan as a breakthrough therapy. On April 24, 2022, the CDE further granted priority review to the drug’s marketing application for use as a monotherapy to treat adult patients with unresectable or metastatic HER2-positive breast cancer who have previously received one or more anti-HER2 therapies. This is also the indication for which the drug was approved this time.