- The U.S. Food and Drug Administration (FDA) on Friday approved the cancer medication Enhertu developed by AstraZeneca ( NASDAQ: AZN ) and its Japanese partner Daiichi Sankyo ( OTCPK:DSKYF ) ( OTCPK:DSNKY ) for adult patients with HER2-low breast cancer.
- HER2 is a tyrosine kinase receptor growth-promoting protein detected in many tumor types including breast cancer. About half of all breast cancer patients have tumors with low HER2 expression.
- The FDA said that the today’s decision marks the first authorized therapy for HER2-low breast cancer subtype, a newly identified subset of HER2-negative breast cancer.
- “Having therapies that are specially tailored to each patient’s cancer subtype is a priority to ensure access to safe and innovative treatments,” noted acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research.
- Last month, AstraZeneca ( AZN ) and Daiichi Sankyo ( OTCPK:DSKYF ) said announced the FDA’s priority review for the label expansion of Enhertu, also known as trastuzumab deruxtecan. A decision on the supplemental biologics license application (sBLA) was expected in 4Q 2022.
For further details see:
AstraZeneca, Daiichi Sankyo win FDA label expansion for Enhertu in HER2-low breast cancer