Disamba 04, 2024, an ba da izinin amfani da Sabon Magani (NDA) don haɗa TYVYT® (allurar sintilimab) da ELUNATE® (fruquintinib) a China don maganin marasa lafiya da ke fama da ciwon daji na endometrial mai tsanani tare da ciwon daji na Mismatch Repair proficient (pMMR) waɗanda suka gaza maganin da aka yi a baya kuma ba 'yan takarar tiyata ko radiation ba ne. Wannan amincewa ta biyo bayan matsayin bita na farko da kuma ayyana maganin nasara da Hukumar Kayayyakin Lafiya ta Ƙasa (NMPA) ta China ta yi kuma ta kasance alama ta takwas da aka amince da ita don allurar TYVYT® (allurar sintilimab).
An sami goyon bayan amincewa da sharaɗi daga NMPA ta hanyar bayanan matakin rajista daga FRUSICA-1, ƙungiyar rajistar ciwon daji ta endometrial na wani bincike mai cibiya da yawa, mai lakabin Phase 2 wanda ke binciken sintilimab tare da fruquintinib a cikin marasa lafiya da ke fama da ciwon daji na endometrial waɗanda suka fuskanci sake dawowar cutar, ci gaban cutar ko guba mara jurewa tare da magani akan maganin chemotherapy mai tushen platinum. An gabatar da sakamakon FRUSICA-1 a taron shekara-shekara na American Society of Clinical Oncology a watan Yunin 2024.
AAn yi rijistar jimillar maki 98 da ke da matsayin pMMR kuma an karɓi maganin haɗin gwiwa. Duk masu haƙuri sun taɓa samun aƙalla maganin platinum mai layin farko, kuma maki 22.4% sun sami maganin bevacizumab. An taƙaita cikakkun tarihin cututtuka a cikin tebur. Tare da matsakaicin lokacin bin diddigin (95% CI) na 15.7m (14.6, 17.7), maki 87/98 suna da aƙalla sakamakon kimanta ƙari ɗaya bayan tushe (maki masu kimanta inganci), daga cikinsu, ORR da DCR da IRC ta tantance sune 35.6% (CR: 2/87 da PR: 29/87) da 88.5% bi da bi; Ba a kai ga DoR ba kuma ƙimar 9m-DoR shine 80.7%. Daga cikin maki 98, matsakaicin (95% CI) PFS da OS sune 9.5m (5.6, -) da 21.3m (17.3, -) bi da bi. Dangane da maganin bevacizumab da ya gabata, ORR shine 40.9% idan aka kwatanta da 30.3%, kuma matsakaicin (95% CI) PFS shine 13.8m (4.1, -) idan aka kwatanta da 9.5m (5.5, -).
Abubuwan da suka faru marasa kyau sun yi daidai da waɗanda aka ruwaito don irin waɗannan magungunan rigakafi da magungunan hana angiogenesis.
Game da Sintilimab
Sintilimab, wanda aka tallata shi a matsayin TYVYT (allurar sintilimab) a ƙasar Sin, wani nau'in rigakafi ne na PD-1 immunoglobulin G4 monoclonal antibody wanda Innovent da Eli Lilly and Company suka haɓaka tare. Sintilimab wani nau'in rigakafi ne na immunoglobulin G4 monoclonal antibody, wanda ke ɗaure da ƙwayoyin PD-1 a saman ƙwayoyin T, yana toshe hanyar PD-1 / PD-Ligand 1 (PD-L1), kuma yana sake kunna ƙwayoyin T don kashe ƙwayoyin cutar kansa. A ƙasar Sin, an amince da sintilimab kuma an haɗa shi cikin NRDL da aka sabunta don alamomi bakwai. An sabunta tsarin biyan kuɗi na NRDL don allurar TYVYT (sintilimab) ya haɗa da:
Don maganin cutar lymphoma ta Hodgkin da ta sake dawowa ko kuma ta sake yin illa bayan an yi mata tiyatar chemotherapy ta hanyar amfani da layi biyu ko fiye;
Don maganin farko na cutar kansar huhu da ba a iya cirewa ba a cikin gida ko kuma wacce ba ta da ƙwayoyin cuta marasa ƙanana waɗanda ba su da ƙwayoyin cuta marasa ƙwayoyin cuta marasa ƙwayoyin cuta marasa ƙwayoyin cuta masu haifar da maye gurbi na kwayoyin halitta na EGFR ko ALK;
Don maganin marasa lafiya da suka kamu da cutar kansar huhu ta EGFR wadda ta yi tsanani a cikin gida ko kuma wadda ba ta kai ga wani ƙaramin ƙwayar halitta ba wadda ba ta kai ga wani abu ba, waɗanda suka ci gaba bayan maganin EGFR-TKI;
Don maganin cutar kansar huhu da ba a iya magancewa ba a gida ko kuma cutar kansar huhu da ba ta da ƙananan ƙwayoyin halitta;
Don maganin cutar kansar hanta wadda ba a iya cirewa ko kuma wadda ta kama da cutar kansar hanta ba tare da wani magani na musamman ba;
Don maganin cutar kansar squamous cell da ba a iya cirewa ba a gida, wadda ta sake dawowa ko kuma ta yaɗuwa a cikin esophageal;
Don maganin ciwon daji na farko wanda ba za a iya cirewa ba a gida, wanda ya sake dawowa ko kuma wanda ya faru a lokacin da aka samu ciwon daji na ciki ko na gastroesophageal.
Bugu da ƙari, NMPA ta amince da maganin na takwas da sintilimab ya bayar, tare da haɗin gwiwa da fruquintinib don maganin marasa lafiya da ke fama da ciwon daji na endometrial mai tsanani tare da ciwon pMMR waɗanda suka gaza a baya a fannin magani kuma ba 'yan takarar tiyata ko radiation ba ne, a watan Disamba na 2024.
Bugu da ƙari, bincike guda biyu na asibiti game da sintilimab sun cika manyan abubuwan da suka haifar da cutar:
Nazarin mataki na 2 na maganin sintilimab monotherapy a matsayin magani na biyu na ciwon daji na esophageal squamous cell carcinoma;
Nazarin mataki na 3 na maganin sintilimab monotherapy a matsayin magani na biyu ga cutar kansar huhu ta squamous non-squamous tare da ci gaban cututtuka bayan maganin chemotherapy na tushen platinum.
Game da Fruquintinib
Fruquintinib magani ne mai hana ci gaban jijiyoyin jini guda uku (“VEGF”) (VEGFR-1, -2 da -3). Masu hana VEGFR suna taka muhimmiyar rawa wajen hana ci gaban ciwon daji. An tsara Fruquintinib don samun ingantaccen zaɓi wanda ke iyakance ayyukan kinase da ba a yi niyya ba, wanda ke ba da damar fallasa magunguna wanda ke cimma ci gaba da hana ci gaba da sassauci don yuwuwar amfani da shi azaman wani ɓangare na maganin haɗin gwiwa.
An amince da Fruquintinib don tallatawa don maganin marasa lafiya da ke fama da ciwon daji na hanji wanda ya taɓa shan fluoropyrimidine, oxaliplatin da irinotecan chemotherapy, da kuma waɗanda suka taɓa shan ko kuma ba su dace da shan maganin anti-VEGF ko maganin anti-epidermal growth factor receptor ("EGFR") (RAS wild-type) a China ba, inda HUTCHMED da Eli Lilly and Company suka haɓaka shi tare kuma suka tallata shi tare da kamfanin a ƙarƙashin sunan ELUNATE. An haɗa shi cikin Jerin Magungunan Biyan Kuɗi na Ƙasa na China (“NRDL”) a watan Janairun 2020. Tun lokacin da aka ƙaddamar da shi a China, an yi wa marasa lafiya sama da 100,000 da ke fama da ciwon daji na hanji magani da fruquintinib.
A watan Disamba na 2024, NMPA ta amince da fruquintinib tare da haɗin gwiwa da sintilimab don maganin marasa lafiya da ke fama da ciwon daji na endometrial mai tsanani tare da ciwon pMMR waɗanda suka gaza a maganin da aka yi amfani da shi a baya kuma ba za a iya yi musu tiyata ko radiation ba.
A halin yanzu, har yanzu akwai gwaje-gwaje da yawa na asibiti na sabbin fasahohin yaƙi da cutar kansa a China waɗanda ke neman marasa lafiya. Tuntuɓi kan sabbin magunguna da fasahohi, zaku iya tuntuɓar Sashen Ƙasa da Ƙasa na Asibitin Oncology na Yankin Kudu na Beijing.
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Imel:myimmnet@163.com
Nassoshi
1.https://www.nmpa.gov.cn/zwfw/sdxx/sdxxyp/yppjfb/20241203153537120.html
2.https://cn.innoventbio.com/#/labarai/592
3.https://meetings.asco.org/abstracts-presentations/234546
4.https://ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.5619
5.https://ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.5619
Lokacin Saƙo: Disamba-16-2024