FDA Gives Regular Approval to AstraZeneca’s and Daiichi Sankyo’s Enhertu for HER2-Positive Breast Cancer

The FDA has granted AstraZeneca’s and Daiichi Sankyo’s potential blockbuster oncology drug, Enhertu (trastuzumab deruxtecan), full approval for patients with unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive breast cancer.

The full approval changes the indications allowed for Enhertu, which received the agency’s accelerated approval for HER2-positive breast cancer in December 2019.

Under the full approval, the drug can now be used in earlier lines of treatment in patients with HER2-positive metastatic breast cancer, the companies said.

Global sales of Enhertu reached $426 million in fiscal 2021, more than double the previous year.