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(Sharecast News) - AstraZeneca's breast cancer treatment candidate 'Enhertu', or trastuzumab deruxtecan, has been approved in the United States, it announced on Monday.
The FTSE 100 pharmaceutical giant said the drug had been approved by the Food and Drug Administration for adults with "unresectable or metastatic HER2-low breast cancer", who had received a previous metastatic chemotherapy or had a recurrence of their cancer during or within six months of an adjuvant chemotherapy.
Enhertu is a "specifically engineered" antibody drug that was being jointly developed by AstraZeneca and Daiichi Sankyo.
The approval was based on results from the 'DESTINY-Breast04' phase 3 trial, in which Enhertu reduced the risk of disease progression or death by 50% versus physician's choice of chemotherapy.
A median overall survival of 23.4 months was seen in patients treated with Enhertu versus 16.8 months in those treated with chemotherapy - a 36% reduction in the risk of death.
"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," said Dave Fredrickson, executive-vice president of AstraZeneca's oncology business unit.
"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."
At 0933 BST, shares in AstraZeneca were down 0.7% at 10,790p.
Reporting by Josh White at Sharecast.com.
