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」）の販売を開始したことをお知らせします。
国立がん研究センター 東病院 副院長 呼吸器内科長 後藤 功一先生は次のように述べています。「このたび発売されたイムデトラは、がん化学療法後に増悪した小細胞肺がん（Small Cell Lung Cancer：SCLC）に対する重要な治療選択肢になると考えます。SCLCは、特に再発後の予後が極めて不良であり、これまで治療選択肢が限られている状況が続いていました。このような背景の中、イムデトラが新たな治療の可能性を提供し、患者さんのアウトカム改善に寄与することが期待されます。今後、実臨床での知見が蓄積され、この治療薬のさらなる有用性が確認されることを願っています。」
当社代表取締役社長のスザナ・ムルテイラは次のように述べています。「本日、日本でイムデトラを発売できることを心より嬉しく思います。イムデトラは、がん化学療法後に増悪したSCLCに対する、約20年ぶりとなる新たな治療選択肢です。アムジェン独自のBiTE®テクノロジーを用いて開発された本剤は、肺がん治療に新たな可能性をもたらす革新的な一歩になると確信しています。今回の発売は、革新的な治療法を一日も早く患者さんのもとへ届けるというアムジェンの揺るぎない使命、そして大きなアンメット・メディカル・ニーズに応えるという私たちの強い意志を、改めて示すものです。」
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4月現在、イムデトラはカナダ、ブラジル、イスラエル、香港、英国および台湾でも承認されています。
製品概要
| 販売名： | 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） |
| 効果又は効能： | がん化学療法後に増悪した小細胞肺癌 |
| 効果又は効能に関連する注意： | 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。 |
| 用法及び用量： | 通常、成人にはタルラタマブ（遺伝子組換え）として、1日目に1mg、8日目に10mgを1回、1時間かけて点滴静注する。15日目以降は1回10mgを1時間かけて2週間間隔で点滴静注する。 |
| 製造販売承認日： | 2024年12月27日 |
| 薬価： |
1mg1瓶（輸液安定化液付）: 137,100円 10mg1瓶（輸液安定化液付）: 1,326,870円 |
| 薬価収載日： | 2025年4月16日 |
| 発売日： | 2025年4月16日 |
| 製造販売： | アムジェン株式会社 |
※詳細は最新の添付文書をご覧ください。
製剤写真
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1,2。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1,3-5。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5。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6。
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7,8。SCLC患者さんの約85％～96％で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9,10,11,12。
BiTE®（二重特異性T細胞誘導）テクノロジーについて
BiTE®テクノロジーは、患者さん自身のT細胞をいずれかの腫瘍特異抗原に誘導し、T細胞の細胞傷害能を活性化することでがん細胞を排除するように設計された、免疫腫瘍療法のプラットフォームです。BiTEプラットフォームは、腫瘍特異抗原を介して様々な種類のがん腫を治療できる可能性があります。BiTEプラットフォームは、全ての医療従事者が必要な時に革新的なT細胞療法を利用できるように開発を進めています。アムジェンは、幅広い種類の血液がんおよび固形がんを対象に複数のBiTE分子の開発に継続して取り組んでおり、より多くの種類のがん種への適応拡大の道を切り拓いています。アムジェンは、患者さんの治療の可能性を広げるために、BiTEテクノロジーのさらなる研究に取り組んでいます。BiTEテクノロジーについての詳細は、BiTE® Technology 101をご参照ください。
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。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。
Amgen Forward-Looking Statements
This news release contains forward-looking statements that are based on the
current expectations and beliefs of Amgen. All statements, other than
statements of historical fact, are statements that could be deemed
forward-looking statements, including any statements on the outcome,
benefits and synergies of collaborations, or potential collaborations, with
any other company (including BeiGene, Ltd. or Kyowa Kirin Co., Ltd.), the
performance of Otezla® (apremilast) (including anticipated Otezla sales
growth and the timing of non-GAAP EPS accretion), Amgen's acquisitions of
Teneobio, Inc., ChemoCentryx, Inc., or Horizon Therapeutics plc (including
the prospective performance and outlook of Horizon's business, performance
and opportunities, any potential strategic benefits, synergies or
opportunities expected as a result of such acquisition, and any projected
impacts from the Horizon acquisition on Amgen's acquisition-related expenses
going forward), as well as estimates of revenues, operating margins, capital
expenditures, cash, other financial metrics, expected legal, arbitration,
political, regulatory or clinical results or practices, customer and
prescriber patterns or practices, reimbursement activities and outcomes,
effects of pandemics or other widespread health problems on Amgen's
business, outcomes, progress, and other such estimates and results.
Forward-looking statements involve significant risks and uncertainties,
including those discussed below and more fully described in the Securities
and Exchange Commission reports filed by Amgen, including its most recent
annual report on Form 10-K and any subsequent periodic reports on Form 10-Q
and current reports on Form 8-K. Unless otherwise noted, Amgen is providing
this information as of the date of this news release and does not undertake
any obligation to update any forward-looking statements contained in this
document as a result of new information, future events or otherwise.
No forward-looking statement can be guaranteed and actual results may differ materially from those Amgen projects. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for Amgen to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and Amgen expects similar variability in the future. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints Amgen has selected. Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as Amgen may have believed at the time of entering into such relationship. Also, Amgen or others could identify safety, side effects or manufacturing problems with its products, including its devices, after they are on the market.
Amgen's results may be affected by its ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing its products and global economic conditions. In addition, sales of Amgen's products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, Amgen's research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Amgen's business may be impacted by government investigations, litigation and product liability claims. In addition, Amgen's business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. If Amgen fails to meet the compliance obligations in the corporate integrity agreement between Amgen and the U.S. government, Amgen could become subject to significant sanctions. Further, while Amgen routinely obtains patents for its products and technology, the protection offered by its patents and patent applications may be challenged, invalidated or circumvented by its competitors, or Amgen may fail to prevail in present and future intellectual property litigation. Amgen performs a substantial amount of its commercial manufacturing activities at a few key facilities, including in Puerto Rico, and also depends on third parties for a portion of its manufacturing activities, and limits on supply may constrain sales of certain of its current products and product candidate development. An outbreak of disease or similar public health threat, such as COVID-19, and the public and governmental effort to mitigate against the spread of such disease, could have a significant adverse effect on the supply of materials for Amgen's manufacturing activities, the distribution of Amgen's products, the commercialization of Amgen's product candidates, and Amgen's clinical trial operations, and any such events may have a material adverse effect on Amgen's product development, product sales, business and results of operations. Amgen relies on collaborations with third parties for the development of some of its product candidates and for the commercialization and sales of some of its commercial products. In addition, Amgen competes with other companies with respect to many of its marketed products as well as for the discovery and development of new products. Further, some raw materials, medical devices and component parts for Amgen's products are supplied by sole third-party suppliers. Certain of Amgen's distributors, customers and payers have substantial purchasing leverage in their dealings with Amgen. The discovery of significant problems with a product similar to one of Amgen's products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on its business and results of operations. Amgen's efforts to collaborate with or acquire other companies, products or technology, and to integrate the operations of companies or to support the products or technology Amgen has acquired, may not be successful. There can be no guarantee that Amgen will be able to realize any of the strategic benefits, synergies or opportunities arising from the Horizon acquisition, and such benefits, synergies or opportunities may take longer to realize than expected. Amgen may not be able to successfully integrate Horizon, and such integration may take longer, be more difficult or cost more than expected. A breakdown, cyberattack or information security breach of Amgen's information technology systems could compromise the confidentiality, integrity and availability of Amgen's systems and Amgen's data. Amgen's stock price may be volatile and may be affected by a number of events. Amgen's business and operations may be negatively affected by the failure, or perceived failure, of achieving its environmental, social and governance objectives. The effects of global climate change and related natural disasters could negatively affect Amgen's business and operations. Global economic conditions may magnify certain risks that affect Amgen's business. Amgen's business performance could affect or limit the ability of the Amgen Board of Directors to declare a dividend or its ability to pay a dividend or repurchase its common stock. Amgen may not be able to access the capital and credit markets on terms that are favorable to it, or at all.
Any scientific information discussed in this news release relating to new indications for Amgen's products is preliminary and investigative and is not part of the labeling approved by the U.S. Food and Drug Administration for the products. The products are not approved for the investigational use(s) discussed in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses.
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。
###
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
References