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Press release
2021年03月12日 09時00分
Source:
Eisai
エーザイ、抗がん剤「レンビマ(R)」(レンバチニブ)が日本において「予定される効能又は効果」としての子宮体がんについて、厚生労働省より希少疾病用医薬品に指定
東京, 2021年03月12日 - (JCN Newswire) - エーザイ株式会社(本社:東京都、代表執行役CEO:内藤晴夫)は、このたび、自社創製の経口マルチキナーゼ阻害剤「レンビマ(R)」(一般名:レンバチニブメシル酸塩)について、子宮体がんを予定される効能又は効果として、厚生労働省より希少疾病用医薬品(オーファンドラッグ)に指定されたことをお知らせします。
日本における子宮体がんの患者様数は約3万人と推定されており1、2020年の新規罹患者数は1万7千人以上、また、3千人以上が亡くなったと推定されています2。子宮体がんのうち、9割以上を子宮内膜がんが占めるとされています3。
「レンビマ」は、「キイトルーダ(R)」(一般名:ペムブロリズマブ)との併用療法について、少なくとも1レジメンのプラチナ製剤による前治療歴のある進行性子宮内膜がん(日本では進行性子宮体がん)を対象とした臨床第III相試験(309/KEYNOTE-775試験)を日本、米国、欧州などで実施しています。本試験において「レンビマ」と「キイトルーダ」の併用療法は、全生存期間と無増悪生存期間の二つの主要評価項目および奏効率の副次評価項目を達成し、現在、日本を含む世界各国で、本試験のデータに基づく効能・効果追加申請の準備中です。
「レンビマ」について、当社は、2018年3月にMerck & Co., Inc., Kenilworth, N.J., U.S.A.とグローバルな共同開発と共同販促を行う戦略的提携契約を締結しています。
当社は、がん領域を重点領域の一つと位置づけており、がんの「治癒」に向けた画期的な新薬創出をめざしています。「レンビマ」によるがん治療の可能性の拡大を引き続き追求し、がん患者様とそのご家族の多様なニーズの充足とベネフィット向上により一層貢献してまいります。
本リリースの詳細は下記をご参照ください。
https://www.eisai.co.jp/news/2021/news202113.html
概要:エーザイ株式会社
詳細は www.eisai.co.jp をご覧ください。
Source: Eisai
セクター: バイオテック
Copyright ©2025 JCN Newswire. All rights reserved. A division of Japan Corporate News Network.
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