アムジェン株式会社（本社：東京、代表取締役社長：スザナ・ムルテイラ、以下「当社」）は、本日、がん化学療法後に増悪した小細胞肺癌を効能又は効果としたデルタ様リガンド3（DLL3）を標的とするBiTE®（二重特異性T細胞誘導）分子製剤であるイムデトラ®点滴静注用1mg・10mg（一般名：タルラタマブ［遺伝子組換え］、以下「イムデトラ」）の日本における電子化された添付文書（以下「電子添文」）が改訂されたことをお知らせします。
今回の電子添文の主な改訂は、プラチナ製剤をベースとした一次化学療法施行後に進行した 小細胞肺がん（SCLC）患者を対象にイムデトラの有効性および安全性を評価する国際共同第III相、ランダム化、非盲検臨床試験 （DeLLphi-304試験）の結果に基づくものです。DeLLphi-304試験のデータは、2025年米国臨床腫瘍学会（ASCO）年次総会でLate-Breaking演題として発表されると同時に、The New England Journal of Medicineに掲載されました1。
イムデトラは2024年2月9日付で厚生労働省より希少疾病用医薬品の指定を受けています。また、イムデトラは2024年5月に米国で優先審査（Priority Review）に基づき規制当局からの承認を取得しました。2025年12月現在、イムデトラはカナダ、ブラジル、イスラエル、香港、英国、台湾、シンガポール、オーストラリア、韓国、アルゼンチン、タイ、アラブ首長国連邦およびクウェートでも承認されています。
| 改訂前 | 改訂後（ ：削除箇所） |
| 5. 効能又は効果に関連する注意 本剤の一次治療及び二次治療における有効性 及び安全性は確立していない。 |
5. 効能又は効果に関連する注意 本剤の一次治療及び二次治療における有効性 及び安全性は確立していない。 |
※詳細は最新の電子添文をご覧ください。
小細胞肺がん（SCLC）について
肺がんは世界で2番目に診断数の多いがんであり、世界および日本におけるがんの部位別死亡原因の第一位です2,3。SCLCは肺がん全体の約15％を占め、世界で毎年33万人超が新規にSCLCと診断されていると推計されています2,4-6。SCLCは最も悪性度が高く深刻な固形がんの一つであり、増殖速度が非常に早く、早期に転移しやすい特徴を有しています6。SCLCの長期予後は不良であり、全てのステージにおける5年相対生存率は10％未満であると報告されています7。
イムデトラ（タルラタマブ［遺伝子組換え］）について
イムデトラは、アムジェン社の研究者によって創製されたファースト・イン・クラスの免疫腫瘍療法であり、T細胞上のCD3とSCLC細胞上のDLL3の両方に結合することで、患者さん自身のT細胞をSCLC細胞の近くに誘導します。これにより、免疫シナプスが形成され、がん細胞が溶解されます8,9。SCLC患者さんの最大96％においてSCLC細胞の表面にDLL3が発現しており、正常細胞での発現は極めて少ないことから、DLL3はSCLC患者さんにとって有望な治療標的であるとされています10,11,12,13。
アムジェン株式会社について
アムジェン株式会社は、世界最大規模の独立バイオテクノロジー企業である米国アムジェン社の日本法人です。アムジェン株式会社では、循環器疾患、がん、骨疾患、炎症・免疫性疾患、神経疾患、希少疾患を始めとするアンメット・メディカル・ニーズが高い領域に焦点を絞り、「To serve patients – 患者さんのために、今できるすべてを」というミッションのもと、臨床開発から販売までの活動を行っています。詳細については https://www.amgen.co.jp/をご覧になるか、https://www.facebook.com/amgenjapan をフォローしてください。
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注意事項（アムジェン株式会社）
このニュースリリースに含まれている医薬品（開発中のものを含む）に関する情報は、宣伝広告、医学的アドバイスを目的とするものではありません。
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この件に関するお問い合わせ先
アムジェン株式会社（東京）
コーポレート・アフェアーズ
jpto-mediarelationsgroup@amgen.com
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