アストラゼネカのダラツマブ、米国で転移性肺がんのファストトラック指定を取得
This Fast Track designation could expedite the development and review of datopotamab deruxtecan, potentially bringing a new treatment option to a large patient population with advanced lung cancer who have limited choices after initial therapies fail.
AstraZeneca and Daiichi Sankyo's datopotamab deruxtecan received US FDA Fast Track designation for advanced or metastatic non-squamous NSCLC patients who have undergone prior systemic therapy.
アストラゼネカと第一三共社のダラツマブ（TROP2指向性抗体薬物複合体）は、先行する全身療法を受けた成人患者の局所進行または転移性非扁平上皮非小細胞肺がん（NSCLC）の治療薬として、米国FDAからファストトラック指定を受けました。この指定は、標準化学療法と比較して無増悪生存期間の有意な改善を示したTROPION-Lung01第III相試験に基づいています。
This Fast Track designation could expedite the development and review of datopotamab deruxtecan, potentially bringing a new treatment option to a large patient population with advanced lung cancer who have limited choices after initial therapies fail. It strengthens AstraZeneca and Daiichi Sankyo's position in the competitive ADC market for oncology.
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https://www.astrazeneca.com/media-centre/press-releases/2026/datopotamab-deruxtecan-granted-fast-track-designation-in-us-for-metastatic-non-small-cell-lung-cancer.html
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