- The U.S. FDA has granted an additional approval to AstraZeneca ( NASDAQ: AZN ) and Daiichi Sankyo's ( OTCPK:DSNKY ) ( OTCPK:DSKYF ) Enhertu (trastuzumab deruxtecan) for HER2-low breast cancer .
- The approval is the first for a targeted therapy for the breast cancer subtype, a subset of HER2-negative breast cancer.
- The agency said that 80%-85% of new breast cancer cases are considered to be HER2-negative. Of that number, ~60% of those are considered HER2-low.
- The current standard of care for HER2-low breast cancer is endocrine therapy or chemotherapy.
- Enhertu was approved in the new indication based on the results from the DESTINY-Breast04 trial which enrolled 557 patients with unresectable or metastatic HER2-low breast cancer.
- The FDA's approval was quite rapid. The companies submitted a supplemental Biologics License Application at the end of July and a decision was expected in Q4 .
For further details see:
AstraZeneca, Daiichi Sankyo's Enhertu approved for HER2-low breast cancer