FDA Approves AstraZeneca And Daiichi Sankyo's Enhertu For Solid Tumors Treatment

(RTTNews) - The U.S. Food and Drug Administration approved AstraZeneca (AZN.L, AZN) and Daiichi Sankyo's (DSKYF.PK) Enhertu (fam-trastuzumab deruxtecan-nxki) for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options.

The indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Enhertu is a specifically engineered HER2-directed antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialized by AstraZeneca and Daiichi Sankyo.

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