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：スティーブ・スギノ）は、現在国内で開発中のKRAS G12C阻害剤sotorasib（開発コード：AMG 510）が、KRAS G12C変異陽性の切除不能な進行・再発の非小細胞肺癌（NSCLC）の適応について、厚生労働省より希少疾病用医薬品の指定を受けましたのでお知らせします。
本邦における肺癌の総患者数は約16.9万人と報告されており1、うちNSCLC患者の割合は85~90％です2。KRAS G12CはNSCLCにおいて最も高い頻度で認められるドライバー変異の一つであり、米国では肺腺癌の約13%3、日本人では非扁平上皮癌の4.5%に認められると報告されています4。KRAS G12C変異を有するNSCLCの二次治療における転帰は不良であり、高いアンメット・メディカル・ニーズが存在します5。
SotorasibはKRAS G12Cを阻害する化合物として世界で初めて臨床試験が開始され、現在は幅広い臨床開発プログラムによる研究が、5つの大陸を含む世界中の臨床試験実施施設で進められています。Sotorasibは臨床試験において良好なベネフィット・リスク・プロファイルを示しており、1日1回の経口投与によって、KRAS G12C変異を有するNSCLC患者に対する迅速かつ持続的で良好な抗腫瘍効果が認められています。
Sotorasibは米国および中国においてBreakthrough Therapy Designation（ブレークスルー・セラピー指定）を受けており、米国、欧州連合（EU）、オーストラリア、ブラジル、カナダ、英国で承認申請を行っています。アムジェンは可能な限り早くsotorasibをNSCLCの患者さんに提供するべく、世界中の規制当局と協働してまいります。
Sotorasibについて
アムジェンは、がん研究において過去40年間で最も困難な課題の一つに取り組んでおり、KRAS G12Cを阻害する治験薬sotorasibを開発しています6。 Sotorasibは、KRAS G12Cを阻害する化合物として世界で初めて臨床試験が開始され、現在では10種類の併用療法の探索的な検討を含む幅広い臨床開発プログラムが、5つの大陸を含む世界中の臨床試験実施施設で進められています。現時点で、sotorasibの臨床開発プログラムにおいて、臨床試験開始からわずか2年間で13種類のがん種にわたり700例を超える、最も多くの臨床試験データが得られています。
Sotorasibは良好なベネフィット・リスク・プロファイルを示しており、1日1回の経口投与によって、KRAS G12C変異を有するNSCLC患者に対する迅速かつ持続的で良好な抗腫瘍効果が認められています。複数のその他の固形がんに対しても、有望な効果が確認されています7。
アムジェン・オンコロジーについて
アムジェン・オンコロジーは、がん治療を進展させ、がん患者さんとそのご家族の生活がより良いものとなるために、日々複雑な課題に対する答えを探求し、導き出しています。私たちの研究は、患者さんが主体的にご自身の生活を送ることができるように、患者さんのがんの疾患ジャーニーに留まらず、生活のコンテクストの中で疾患を理解することを目指しています。
過去40年の間、私たちは、オンコロジー領域において重要な発見を成し遂げること、またがんがもたらす負荷を軽減する方法を見つけることに注力してきました。この伝統を基盤として、アムジェンは、私たちが生み出したイノベーションを必要とする患者さんに一日も早くお届けするべく、創業以来最大の創薬パイプラインを進展させ続けていきます。
アムジェンにおいて、私たちの活動はがん患者さんの生活を変革するというコミットメントによって加速します。患者さんは私たちが行うあらゆる活動の中心にいらっしゃいます。
詳細については、www.twitter.com/amgenoncologyをフォローしてください。
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。2013年10月にアステラス製薬との合弁会社であるアステラス・アムジェン・バイオファーマとして事業を開始し、2020年4月1日にアムジェン社の完全子会社となり商号を変更しました。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、現在約600人の従業員が、「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。
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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）
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TEL 03-4590-1771