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- The U.S. FDA has given the green light for a potential label expansion of Enhertu, an antibody-drug conjugate (ADC) co-developed by AstraZeneca and Daiichi Sankyo (OTCPK:DSKYF) (OTCPK:DSNKY).
- The regulator has agreed to prioritize the review of the supplemental Biologics License Application (sBLA) submitted by the companies, with a decision date set for May 30, 2024, under the Prescription Drug User Fee Act (PDUFA).
- With this submission, AstraZeneca and Daiichi Sankyo are seeking approval to use Enhertu in adults with solid tumors expressing the HER2 protein, offering a late-line option or for those with no alternative treatment.
- Enhertu, also known as trastuzumab deruxtecan, is already approved in the U.S. for multiple forms of tumors, including HER2-positive breast cancer and HER-2-positive non-small-cell lung cancer.
