Amgen Worldwide
A biotechnology pioneer since 1980, Amgen has reached millions of patients around the world.
オンラインリソース
アムジェンは、患者さんが関心のある分野について学べるよう、多数のリソースを用意しております。
疾患教育
重点領域
A biotechnology pioneer since 1980, Amgen has reached millions of patients around the world.
アムジェンは、患者さんが関心のある分野について学べるよう、多数のリソースを用意しております。
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」）はこのたび、KRAS G12C阻害剤であるルマケラス®錠（一般名：ソトラシブ、以下「ルマケラス」）について、KRAS G12C変異陽性の治癒切除不能な進行・再発の結腸・直腸がんに対し、ベクティビックス®点滴静注（一般名：パニツムマブ（遺伝子組換え）、以下「ベクティビックス」）※との併用療法として、日本国内における効能又は効果の追加に係る製造販売承認事項一部変更承認申請（以下「一変申請」）を行いましたので、お知らせいたします。
結腸・直腸がん（Colorectal Cancer：CRC）は全世界で男女ともに3番目に多く診断されるがんであり、がんの部位別死亡原因の第2位です1。日本では、2022年のCRC罹患数は15.8万人、死亡数は5.4万人と推定されており、臨床病期IV期のCRC患者の5年相対生存率は23％であると報告されています2,3。
CRC患者の約3％がKRAS G12C変異を有すると推定されています4,5。また、KRAS G12C変異を有する患者は、他のKRAS遺伝子変異を有する患者と比較して予後が悪いことが報告されています6,7。現在、日本においてKRAS G12C変異を含むKRAS変異を標的としたCRCに対する治療薬は承認されておらず、KRAS変異陰性CRC患者と比較して治療選択肢が少ないため、大きなアンメット・メディカル・ニーズが存在しています5,8,9。
今回の一変申請は、KRAS G12C変異陽性の既治療の転移性CRC患者を対象として、ルマケラスの2用量（240mgまたは960mg）とベクティビックスを併用投与した際の有効性および安全性を評価する、第III相、国際共同、多施設共同、ランダム化、非盲検、実薬対照試験（CodeBreaK 300試験）から得られた結果に基づき行いました。本試験では、主要評価項目である中央判定に基づく無増悪生存期間において、ルマケラス960mgとベクティビックスの併用投与群で、治験担当医師が選択した標準治療群と比較して統計学的に有意な延長が示されました。また、ルマケラス960mgとベクティビックスの併用投与で認められた有害事象は、いずれも個々の薬剤で報告されている既知の安全性プロファイルと同様で、併用による新たな安全性の懸念は認められず、併用投与による安全性プロファイルは許容可能でした。
現在、日本におけるルマケラスの効能又は効果は「がん化学療法後に増悪したKRAS G12C変異陽性の切除不能な進行・再発の非小細胞肺癌」です。
当社は可能な限り早くルマケラスをCRCの患者さんに提供するべく、規制当局と協働してまいります。
ルマケラス®（ソトラシブ）について
ルマケラスはKRAS G12C変異タンパクに特異的に結合し、不可逆的に阻害する低分子化合物であり、KRAS G12C変異を有する固形がんに対する開発を進めています。
ルマケラスは、KRAS G12C変異を有する局所進行または転移性非小細胞肺がん（NSCLC）の治療薬として、960 mg1日1回の用量で、2021年5月28日に米国において世界で初めて承認を取得しました。2024年11月現在、ルマケラスは50カ国以上で現行承認されている唯一の適応症であるNSCLCに対する治療薬として承認を取得しています。
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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アムジェン株式会社（東京）
コーポレート・アフェアーズ
TEL 080-4950-6230
References