AstraZeneca PLC (LSE:AZN) hailed as ‘transformational’ a breast cancer treatment that has received a fast-track sign-off by the US Food & Drug Administration.
Enhertu, which AZ jointly developed with Japan’s Daiichi Sankyo, has been approved for use in women with the HER-2 form of the disease where the tumour can’t be operated on or where the cancer has spread.
"The rapid approval of Enhertu in HER2-low metastatic breast cancer by the FDA underscores the urgency to bring this transformational medicine to patients as quickly as possible,” Dave Fredrickson, vice-president of AZ’s oncology business.
“Patients with HER2-low tumours, who are identified through existing HER2 testing methods, will now have the opportunity to be treated based upon their HER2 status."