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AstraZeneca, Daiichi Sankyo's Enhertu Gets China's Conditional Approval for New Indication

MT Newswires·10/23/2026 09:25:34
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09:25 AM EDT, 10/23/2026 (MT Newswires) -- AstraZeneca (AZN.L, AZN.ST) and Daiichi Sankyo's Enhertu received conditional approval in China for a new indication based on the results of single-arm trials, according to a Thursday release. China's National Medical Products Administration approved Enhertu, or trastuzumab deruxtecan, as a monotherapy for adult patients with unresectable or metastatic solid tumors that have HER2 expression, who have been treated before or have no satisfactory alternative options. According to results from four phase 2 trials, namely Destiny-PanTumor02, Destiny-Lung01, Destiny-CRC02 and Destiny-PanTumor03, Enhertu showed "clinically meaningful" responses across a broad range of tumors. Full approval of the indication will be subject to the clinical benefit of a confirmatory trial and brings the drug's total approved indications in China to 10.