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←建立内容为“{{Medical}} {{Infobox drug | drug_name = | INN = | type = <!-- empty --> | image = Futibatinib.svg | width = | alt = | caption = <!-- Clinical data --> | pronounce = | tradename = Lytgobi | Drugs.com = {{drugs.com|cons|futibatinib}} | MedlinePlus = | licence_CA = <!-- Health Canada may use generic or brand name (generi…”的新页面
 
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| legal_US_comment = <ref name="Lytgobi FDA label">{{cite web | title=Lytgobi- futibatinib tablet | website=DailyMed | date=2 February 2023 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0b1332a1-0581-4707-9bf6-1eccfa39bef4 | access-date=13 April 2023 | archive-date=12 April 2023 | archive-url=https://web.archive.org/web/20230412133502/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0b1332a1-0581-4707-9bf6-1eccfa39bef4 | url-status=live }}</ref><ref name="FDA futibatinib" /><ref name="Lytgobi Drug Approval Package" />
| legal_US_comment = <ref name="Lytgobi FDA label">{{cite web | title=Lytgobi- futibatinib tablet | website=DailyMed | date=2 February 2023 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0b1332a1-0581-4707-9bf6-1eccfa39bef4 | access-date=13 April 2023 | archive-date=12 April 2023 | archive-url=https://web.archive.org/web/20230412133502/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0b1332a1-0581-4707-9bf6-1eccfa39bef4 | url-status=live }}</ref><ref name="FDA futibatinib" /><ref name="Lytgobi Drug Approval Package" />
| legal_EU = Rx-only
| legal_EU = Rx-only
| legal_EU_comment = <ref name="Lytgobi EU">{{cite web | title=Lytgobi | website=Union Register of medicinal products | date=6 July 2023 | url=https://ec.europa.eu/health/documents/community-register/html/h1741.htm | access-date=14 July 2023 | archive-date=14 July 2023 | archive-url=https://web.archive.org/web/20230714201937/https://ec.europa.eu/health/documents/community-register/html/h1741.htm | url-status=live }}</ref><ref>{{cite web | title=Lytgobi EPAR | website=European Medicines Agency | date=18 July 2023 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/lytgobi | access-date=25 August 2023}}</ref>
| legal_EU_comment = <ref name="Lytgobi EU">{{cite web | title=Lytgobi | website=Union Register of medicinal products | date=6 July 2023 | url=https://ec.europa.eu/health/documents/community-register/html/h1741.htm | access-date=14 July 2023 | archive-date=14 July 2023 | archive-url=https://web.archive.org/web/20230714201937/https://ec.europa.eu/health/documents/community-register/html/h1741.htm | url-status=live }}</ref><ref>{{cite web | title=Lytgobi EPAR | website=European Medicines Agency | date=18 July 2023 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/lytgobi | access-date=25 August 2023 | archive-date=2024-10-07 | archive-url=https://web.archive.org/web/20241007143543/https://www.ema.europa.eu/en/medicines/human/EPAR/lytgobi | dead-url=no }}</ref>
| legal_UN = <!-- N I, II, III, IV / P I, II, III, IV -->
| legal_UN = <!-- N I, II, III, IV / P I, II, III, IV -->
| legal_UN_comment =
| legal_UN_comment =
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'''福巴替尼'''（[[国际非专有药名|INN]]：futibatinib<ref>{{cite journal |author-link=World Health Organization |vauthors=((World Health Organization)) |title=International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 81 |journal=WHO Drug Information |year=2019 |volume=33 |issue=1 |page= |hdl=10665/330896 |hdl-access=free}}</ref>），商品名'''Lytgobi'''，又称'''富替巴替尼'''，是由日本大鹏制药（Taiho Pharmaceutical）研制的一款治疗局部晚期或转移性肝内[[膽管癌|胆管癌]]的口服药<ref name="Lytgobi FDA label" /><ref name="Lytgobi Drug Approval Package">{{cite web|title=Drug Approval Package: Lytgobi|url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/214801Orig1s000TOC.cfm|date=8 November 2022|url-status=live|archive-url=https://web.archive.org/web/20221119000146/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/214801Orig1s000TOC.cfm|archive-date=19 November 2022|access-date=18 November 2022|publisher=U.S. [[Food and Drug Administration]] (FDA)}}</ref><ref name=":0">{{Cite journal |author=许忠凯 |title=富替巴替尼(Futibatinib,Lytgobi) |url=https://d.wanfangdata.com.cn/periodical/ChlQZXJpb2RpY2FsQ0hJTmV3UzIwMjQwNzA0EhF6Z3l3aHh6ejIwMjMwNDAxMRoIZHRpbG1zNHU%3D |journal=中国药物化学杂志 |year=2023 |volume=33 |issue=4 |page=320 |doi=10.14142/j.cnki.cn21-1313/r.2023.04.011}}</ref>。为[[成纤维细胞生长因子受体|成纤维细胞生长因子受体2]]（FGFR2）不可逆抑制剂，用于治疗FGFR2基因融合的既往接受过治疗且无法切除的局部晚期或转移性肝内胆管癌的成年患者<ref name=":0" /><ref name="Lytgobi FDA label" /><ref name="Lytgobi Drug Approval Package" /><ref name="FDA futibatinib">{{cite web|title=FDA grants accelerated approval to futibatinib for cholangiocarcinoma|url=https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-futibatinib-cholangiocarcinoma|date=30 September 2022|url-status=live|archive-url=https://web.archive.org/web/20221204073236/https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-futibatinib-cholangiocarcinoma|archive-date=4 December 2022|access-date=4 December 2022|publisher=U.S. Food and Drug Administration}} {{PD-notice}}</ref><ref name="pmid37390492">{{cite journal |vauthors=Javle M, King G, Spencer K, Borad MJ |title=Futibatinib, an Irreversible FGFR1-4 Inhibitor for the Treatment of FGFR-Aberrant Tumors |url= |journal=The Oncologist |date=November 2023 |volume=28 |issue=11 |pages=928–943 |doi=10.1093/oncolo/oyad149 |pmc=10628593 |pmid=37390492}}</ref>。
'''福巴替尼'''（[[国际非专有药名|INN]]：futibatinib<ref>{{cite journal |author-link=World Health Organization |vauthors=((World Health Organization)) |title=International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 81 |journal=WHO Drug Information |year=2019 |volume=33 |issue=1 |page= |hdl=10665/330896 |hdl-access=free}}</ref>），商品名'''Lytgobi'''，又称'''富替巴替尼'''，是由日本大鹏制药（Taiho Pharmaceutical）研制的一款治疗[[膽管癌|胆管癌]]的口服药<ref name="Lytgobi FDA label" /><ref name="Lytgobi Drug Approval Package">{{cite web|title=Drug Approval Package: Lytgobi|url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/214801Orig1s000TOC.cfm|date=8 November 2022|url-status=live|archive-url=https://web.archive.org/web/20221119000146/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/214801Orig1s000TOC.cfm|archive-date=19 November 2022|access-date=18 November 2022|publisher=U.S. [[Food and Drug Administration]] (FDA)}}</ref><ref name=":0">{{Cite journal |author=许忠凯 |title=富替巴替尼(Futibatinib,Lytgobi) |url=https://d.wanfangdata.com.cn/periodical/ChlQZXJpb2RpY2FsQ0hJTmV3UzIwMjQwNzA0EhF6Z3l3aHh6ejIwMjMwNDAxMRoIZHRpbG1zNHU%3D |journal=中国药物化学杂志 |year=2023 |volume=33 |issue=4 |page=320 |doi=10.14142/j.cnki.cn21-1313/r.2023.04.011}}</ref>。为[[成纤维细胞生长因子受体|成纤维细胞生长因子受体2]]（FGFR2）不可逆抑制剂，用于治疗FGFR2基因融合的既往接受过治疗且无法切除的局部晚期或转移性肝内胆管癌的成年患者<ref name=":0" /><ref name="Lytgobi FDA label" /><ref name="Lytgobi Drug Approval Package" /><ref name="FDA futibatinib">{{cite web|title=FDA grants accelerated approval to futibatinib for cholangiocarcinoma|url=https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-futibatinib-cholangiocarcinoma|date=30 September 2022|url-status=live|archive-url=https://web.archive.org/web/20221204073236/https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-futibatinib-cholangiocarcinoma|archive-date=4 December 2022|access-date=4 December 2022|publisher=U.S. Food and Drug Administration}} {{PD-notice}}</ref><ref name="pmid37390492">{{cite journal |vauthors=Javle M, King G, Spencer K, Borad MJ |title=Futibatinib, an Irreversible FGFR1-4 Inhibitor for the Treatment of FGFR-Aberrant Tumors |url= |journal=The Oncologist |date=November 2023 |volume=28 |issue=11 |pages=928–943 |doi=10.1093/oncolo/oyad149 |pmc=10628593 |pmid=37390492}}</ref>。


2022年9月通过美国[[美国食品药品监督管理局|FDA]]批准<ref name="FDA futibatinib" /><ref name="Lytgobi Drug Approval Package" />，2023年6月在日本获批<ref>{{Cite web|title=Taiho Pharmaceutical Obtains Approval in Japan to Manufacture and Market FGFR Inhibitor LYTGOBI® Tablets 4mg for Unresectable Biliary Tract Cancer Harboring FGFR2 Gene Fusions That Has Progressed After Chemotherapy|url=https://www.taiho.co.jp/en/release/2023/20230626.html|website=Taiho Pharmaceutical Co., Ltd.|date=26 June 2023|access-date=17 August 2023}}</ref><ref name="pmid36441501">{{cite journal |vauthors=Syed YY |title=Futibatinib: First Approval |url=https://figshare.com/articles/online_resource/Futibatinib_First_Approval/21508350 |journal=Drugs |date=December 2022 |volume=82 |issue=18 |pages=1737–1743 |doi=10.1007/s40265-022-01806-z |pmid=36441501}}</ref>，并于同年7月在欧盟获批<ref name="Lytgobi EU" /><ref>{{cite press release|title=European Commission Grants Conditional Marketing Authorization for Taiho's Lytgobi Tablets for the Treatment of Adults With Cholangiocarcinoma|publisher=Taiho Oncology Europe|via=PR Newswire|date=4 July 2023|url=https://www.prnewswire.com/news-releases/european-commission-grants-conditional-marketing-authorization-for-taihos-lytgobi-tablets-for-the-treatment-of-adults-with-cholangiocarcinoma-301869543.html|access-date=14 July 2023}}</ref>。
2022年9月通过美国[[美国食品药品监督管理局|FDA]]批准<ref name="FDA futibatinib" /><ref name="Lytgobi Drug Approval Package" />，2023年6月在日本获批<ref>{{Cite web|title=Taiho Pharmaceutical Obtains Approval in Japan to Manufacture and Market FGFR Inhibitor LYTGOBI® Tablets 4mg for Unresectable Biliary Tract Cancer Harboring FGFR2 Gene Fusions That Has Progressed After Chemotherapy|url=https://www.taiho.co.jp/en/release/2023/20230626.html|website=Taiho Pharmaceutical Co., Ltd.|date=26 June 2023|access-date=17 August 2023|archive-date=2024-10-07|archive-url=https://web.archive.org/web/20241007113002/https://www.taiho.co.jp/en/release/2023/20230626.html|dead-url=no}}</ref><ref name="pmid36441501">{{cite journal |vauthors=Syed YY |title=Futibatinib: First Approval |url=https://figshare.com/articles/online_resource/Futibatinib_First_Approval/21508350 |journal=Drugs |date=December 2022 |volume=82 |issue=18 |pages=1737–1743 |doi=10.1007/s40265-022-01806-z |pmid=36441501 |access-date=2024-10-03 |archive-date=2024-10-07 |archive-url=https://web.archive.org/web/20241007091243/https://figshare.com/articles/online_resource/Futibatinib_First_Approval/21508350 |dead-url=no }}</ref>，并于同年7月在欧盟获批<ref name="Lytgobi EU" /><ref>{{cite press release|title=European Commission Grants Conditional Marketing Authorization for Taiho's Lytgobi Tablets for the Treatment of Adults With Cholangiocarcinoma|publisher=Taiho Oncology Europe|via=PR Newswire|date=4 July 2023|url=https://www.prnewswire.com/news-releases/european-commission-grants-conditional-marketing-authorization-for-taihos-lytgobi-tablets-for-the-treatment-of-adults-with-cholangiocarcinoma-301869543.html|access-date=14 July 2023|archive-date=2024-10-07|archive-url=https://web.archive.org/web/20241007122946/https://www.prnewswire.com/news-releases/european-commission-grants-conditional-marketing-authorization-for-taihos-lytgobi-tablets-for-the-treatment-of-adults-with-cholangiocarcinoma-301869543.html|dead-url=no}}</ref>。


== 参考文献 ==
== 参考文献 ==
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[[Category:甲氧基化合物]]
[[Category:甲氧基化合物]]
[[Category:孤儿药]]
[[Category:孤儿药]]
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[[Category:胺類]]
[[Category:吡唑嘧啶]]
[[Category:吡唑嘧啶]]
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[[Category:胺]]
[[Category:酰胺]]

2024年10月8日 (二) 23:26的最新版本

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福巴替尼
臨床資料
商品名（英语：Drug nomenclature）Lytgobi
其他名稱TAS-120，富替巴替尼
AHFS/Drugs.comMicromedex详细消费者药物信息
核准狀況
给药途径口服
藥物類別（英语：Drug class）抗肿瘤药物
ATC碼
法律規範狀態
法律規範
识别信息
  • 1-[(3S)-3-[4-amino-3-[2-(3,5-dimethoxyphenyl)ethynyl]pyrazolo[3,4-d]pyrimidin-1-yl]pyrrolidin-1-yl]prop-2-en-1-one
CAS号1448169-71-8
PubChem CID
IUPHAR/BPS
DrugBank
ChemSpider
UNII
KEGG
ChEMBL
PDB配體ID
化学信息
化学式C22H22N6O3
摩尔质量418.46 g·mol−1
3D模型（JSmol（英语：JSmol））
  • COC1=CC(=CC(OC)=C1)C#CC1=NN([C@H]2CCN(C2)C(=O)C=C)C2=C1C(N)=NC=N2
  • InChI=1S/C22H22N6O3/c1-4-19(29)27-8-7-15(12-27)28-22-20(21(23)24-13-25-22)18(26-28)6-5-14-9-16(30-2)11-17(10-14)31-3/h4,9-11,13,15H,1,7-8,12H2,2-3H3,(H2,23,24,25)/t15-/m0/s1
  • Key:KEIPNCCJPRMIAX-HNNXBMFYSA-N

福巴替尼（INN：futibatinib[6]），商品名Lytgobi，又称富替巴替尼，是由日本大鹏制药（Taiho Pharmaceutical）研制的一款治疗胆管癌的口服药[1][3][7]。为成纤维细胞生长因子受体2（FGFR2）不可逆抑制剂，用于治疗FGFR2基因融合的既往接受过治疗且无法切除的局部晚期或转移性肝内胆管癌的成年患者[7][1][3][2][8]。

2022年9月通过美国FDA批准[2][3]，2023年6月在日本获批[9][10]，并于同年7月在欧盟获批[4][11]。

参考文献

[编辑]
  1. ^ 1.0 1.1 1.2 Lytgobi- futibatinib tablet. DailyMed. 2 February 2023 [13 April 2023]. （原始内容存档于12 April 2023）. 
  2. ^ 2.0 2.1 2.2 FDA grants accelerated approval to futibatinib for cholangiocarcinoma. U.S. Food and Drug Administration. 30 September 2022 [4 December 2022]. （原始内容存档于4 December 2022）.  公有领域 本文含有此來源中屬於公有领域的内容。
  3. ^ 3.0 3.1 3.2 3.3 Drug Approval Package: Lytgobi. U.S. Food and Drug Administration (FDA). 8 November 2022 [18 November 2022]. （原始内容存档于19 November 2022）. 
  4. ^ 4.0 4.1 Lytgobi. Union Register of medicinal products. 6 July 2023 [14 July 2023]. （原始内容存档于14 July 2023）. 
  5. ^ Lytgobi EPAR. European Medicines Agency. 18 July 2023 [25 August 2023]. （原始内容存档于2024-10-07）. 
  6. ^ World Health Organization. International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 81. WHO Drug Information. 2019, 33 (1). hdl:10665/330896 可免费查阅. 
  7. ^ 7.0 7.1 许忠凯. 富替巴替尼(Futibatinib,Lytgobi). 中国药物化学杂志. 2023, 33 (4): 320. doi:10.14142/j.cnki.cn21-1313/r.2023.04.011. 
  8. ^ Javle M, King G, Spencer K, Borad MJ. Futibatinib, an Irreversible FGFR1-4 Inhibitor for the Treatment of FGFR-Aberrant Tumors. The Oncologist. November 2023, 28 (11): 928–943. PMC 10628593 可免费查阅. PMID 37390492. doi:10.1093/oncolo/oyad149. 
  9. ^ Taiho Pharmaceutical Obtains Approval in Japan to Manufacture and Market FGFR Inhibitor LYTGOBI® Tablets 4mg for Unresectable Biliary Tract Cancer Harboring FGFR2 Gene Fusions That Has Progressed After Chemotherapy. Taiho Pharmaceutical Co., Ltd. 26 June 2023 [17 August 2023]. （原始内容存档于2024-10-07）. 
  10. ^ Syed YY. Futibatinib: First Approval. Drugs. December 2022, 82 (18): 1737–1743 [2024-10-03]. PMID 36441501. doi:10.1007/s40265-022-01806-z. （原始内容存档于2024-10-07）. 
  11. ^ European Commission Grants Conditional Marketing Authorization for Taiho's Lytgobi Tablets for the Treatment of Adults With Cholangiocarcinoma (新闻稿). Taiho Oncology Europe. 4 July 2023 [14 July 2023]. （原始内容存档于2024-10-07） –通过PR Newswire. 
检索自“https://zh.wikipedia.org/zhwiki/w/index.php?title=福巴替尼&oldid=84515071”