Telix選擇Cardinal Health發售Gozellix® 影像劑

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Telix 宣布與 Cardinal Health 合作進行 Gozellix 商業分銷

2025年4月8日，澳洲墨爾本和美國印第安納波利斯 — Telix Pharmaceuticals Limited（ASX: TLX, NASDAQ: TLX，簡稱 Telix）今日宣布，已選擇 Cardinal Health, Inc.（NYSE: CAH，簡稱 Cardinal Health）作為其商業放射藥物分銷商之一，負責在美國供應 Gozellix®（用於製備鎵-68（68Ga）gozetotide 注射液的試劑盒），這是 Telix 針對前列腺癌的下一代 PSMA-PET 成像劑。

在最近獲得美國食品藥品監督管理局（FDA）的批准後，Telix 為了在2025年上半年進行商業推出，與 Cardinal Health 簽訂了合約，以確保在美國各地的廣泛可用性。為了支持這次的推廣，Cardinal Health 部署了 Telix 的 ARTMS QUANTM 照射系統（QIS®）回旋加速器技術，這使得鎵-68 的標準化、高效率和成本效益的生產成為可能，並將促進鎵-68 的多居里本地生產。

Telix 精準醫學的首席執行官 Kevin Richardson 表示：「Cardinal Health 是一個極具價值的放射藥房分銷商，其廣泛的地理覆蓋和卓越的服務質量是 Illuccix® 商業成功的關鍵因素。我們很高興能夠在成功的合作基礎上，將基於鎵的成像準確性和臨床實用性帶給全國更多的患者，這是 Gozellix® 的重要一步。」

Cardinal Health 核心與精準健康解決方案的總裁 Mike Pintek 補充道：「我們很高興能夠繼續加強與 Telix 的合作，現在包括 Illuccix®、Zircaix® 和 Gozellix® 的分銷。我們廣泛的商業分銷結構和創新的 ARTMS 生產技術的結合，使我們能夠擴大患者的覆蓋範圍和排程靈活性，為基於鎵的 PSMA 成像提供更多的便利。我們期待將這一新型精準醫學診斷帶給患者及其醫療提供者。」

Cardinal Health 將作為 Gozellix 的戰略放射藥房分銷商，並與 Telix 的內部放射藥房網絡共同運作。

重要安全信息

警告和預防措施

誤解風險
使用 Gozellix PET 進行影像解讀時可能會出現錯誤。陰性影像並不排除前列腺癌的存在，陽性影像也不確認前列腺癌的存在。鎵 Ga-68 gozetotide 的攝取並不專門針對前列腺癌，可能會出現在其他類型的癌症以及非惡性過程中，例如佩吉特病、纖維性發育不良和骨贅。建議進行臨床相關性評估，可能包括對懷疑的前列腺癌部位進行組織病理學評估。

初次確定或懷疑復發治療前的影像檢查
Gozellix 在生化復發前列腺癌影像中的性能似乎受到血清 PSA 水平和疾病部位的影響。在初次確定治療前，Gozellix 在影像檢查轉移性骨盆淋巴結的性能似乎受 Gleason 分數的影響。

輻射風險
鎵 Ga-68 gozetotide 會增加患者的長期累積輻射暴露。長期累積輻射暴露與癌症風險增加有關。確保安全處理以最小化患者和醫療提供者的輻射暴露。建議患者在給藥前後多喝水，並在給藥後經常排尿。

對亞硫酸鹽的過敏反應
抗壞血酸穩定劑含有亞硫酸鈉，這是一種可能引起過敏反應的亞硫酸鹽，包括過敏性症狀和某些易感者的危及生命或較輕微的哮喘發作。一般人群中亞硫酸鹽敏感的整體發病率未知，且可能較低。哮喘患者的亞硫酸鹽敏感性比非哮喘患者更為常見。

不良反應
在 PSMA-PreRP 和 PSMABCR 研究中，對 960 名患者進行了鎵 Ga-68 gozetotide 的安全性評估，每名患者接受一次鎵 Ga-68 gozetotide 注射。平均注射活性為 188.7 ± 40.7 MBq（5.1 ± 1.1 mCi）。最常報告的不良反應為噁心、腹瀉和頭暈，發生率低於 1%。

藥物相互作用
雄激素剝奪療法及其他針對雄激素途徑的療法
雄激素剝奪療法（ADT）及其他針對雄激素途徑的療法，如雄激素受體拮抗劑，可能會導致鎵 Ga-68 gozetotide 在前列腺癌中的攝取變化。這些療法對鎵 Ga-68 gozetotide PET 的性能影響尚未確定。

結語

這次與 Cardinal Health 的合作，標誌著 Telix 在推廣其創新產品 Gozellix® 方面邁出了重要的一步。透過這項合作，Telix 不僅能夠擴大其在美國市場的覆蓋範圍，還能利用 Cardinal Health 的分銷網絡，為更多患者提供先進的前列腺癌成像解決方案。隨著醫療技術的不斷進步，這種合作模式也許能成為未來醫藥行業的一種趨勢，促進更多創新產品的快速上市，從而提升患者的治療體驗和結果。

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