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AstraZeneca s, Daiichi s Enhertu receives US FDA approval

AstraZeneca PLC and Daiichi Sankyo Co Ltd on Saturday announced that the US Food & Drug Administration has approved their cancer drug conjugate for patients with metastatic HER2-positive solid.

TOP NEWS: AstraZeneca s, Daiichi s Enhertu receives US FDA approval

TOP NEWS: AstraZeneca s, Daiichi s Enhertu receives US FDA approval
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AstraZeneca Plc s Enhertu approved in the US for HER2+ solid tumours

AstraZeneca/Daiichi s Flagship Drug Enhertu Secures Accelerated FDA Approval For Pretreated Cancer Patients With Solid Tumor

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 indicat

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