Published on 9 Apr 2024 on Benzinga via Yahoo Finance
AstraZeneca/Daiichi's Flagship Drug Enhertu Secures Accelerated FDA Approval For Pretreated Cancer...
On Friday, the FDA approved Daiichi Sankyo Ltd’s (OTC:DSKYF) (OTC:DSNKY) and AstraZeneca Plc’s (NASDAQ:AZN) Enhertu (fam-trastuzumab deruxtecan-nxki) for unresectable or metastatic HER2 positive (immunohistochemistry [IHC] 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options.
This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.