Ku ya 04 Ukuboza 2024, Porogaramu nshya y'imiti (NDA) yo guhuza TYVYT® (inshinge ya sintilimab) na ELUNATE® (fruquintinib) yemerewe mu Bushinwa kuvura abarwayi bafite kanseri y'inkondo y'umura iteye imbere bafite ibibyimba bya Mismatch Repair proficient (pMMR) byananiwe ubuvuzi bw'umubiri mbere kandi bitari abakandida bo kubagwa cyangwa kuvurwa hakoreshejwe imirasire. Iyi shinge ikurikira isuzuma ry'ibanze ryakozwe n'Ikigo cy'Igihugu gishinzwe Ibikoresho by'Ubuvuzi (NMPA) cy'Ubushinwa, ikaba ari ikimenyetso cya munani cyemewe cyo gutera TYVYT® (inshinge ya sintilimab).
Kwemezwa kwa NMPA byashyigikiwe n'amakuru yo kwiyandikisha yavuye muri FRUSICA-1, itsinda ryiyandikisha kanseri y'inkondo y'umura ryiga mu bushakashatsi bw'icyiciro cya 2 bw'inyigo yakozwe mu bigo byinshi, ifunguye ku barwayi ba kanseri y'inkondo y'umura bahuye n'ikibazo cyo kugaruka kw'indwara, kwiyongera kw'indwara cyangwa uburozi budashobora kwihanganirwa hamwe n'ubuvuzi bwa platine-based doublet chemotherapy. Ibisubizo bya FRUSICA-1 byatanzwe mu nama ngarukamwaka y'Umuryango w'Abanyamerika wita ku ndwara ya kanseri muri Kamena 2024.
AIgiteranyo cy’udukoko 98 twagaragayeho pMMR cyaranditswe kandi cyahawe ubuvuzi buvanze. Abaganga bose bari barahawe nibura ubuvuzi bwa mbere burimo platine, naho 22.4% by’udukoko bahawe bevacizumab. Amateka y’indwara arambuye aravugwa muri iyi mbonerahamwe. Igihe cyo gukurikirana (95% CI) cya 15.7m (14.6, 17.7), udukoko 87/98 twabonye nibura igisubizo kimwe nyuma yo gusuzuma ikibyimba (udukoko twapimwe), muri byo, ORR na DCR byapimwe na IRC byari 35.6% (CR: 2/87 na PR: 29/87) na 88.5% uko bikurikirana; DoR ntiyagezweho kandi igipimo cya 9m-DoR cyari 80.7%. Mu madosiye 98, igipimo cya PFS (95% CI) na OS byari 9.5m (5.6, -) na 21.3m (17.3, -) uko bikurikirana. Hashingiwe ku buvuzi bwa bevacizumab bwabanje, ORR yari 40.9% ugereranije na 30.3%, naho igipimo cya PFS (95% CI) cyari 13.8m (4.1, -) ugereranije na 9.5m (5.5, -).
Ingaruka mbi zihuye n’izavuzwe ku miti isa n’iyi irwanya indwara ndetse n’imiti irwanya anjine.
Ku bijyanye na Sintilimab
Sintilimab, yagurishijwe nka TYVYT (inshinge ya sintilimab) mu Bushinwa, ni antibody ya PD-1 immunoglobulin G4 monoclonal yakozwe na Innovent na Eli Lilly and Company. Sintilimab ni ubwoko bwa antibody ya immunoglobulin G4 monoclonal, ifatana na molekile za PD-1 ku buso bwa T-cells, igafunga inzira ya PD-1 / PD-Ligand 1 (PD-L1), kandi igasubizamo T-cells kugira ngo yica uturemangingo twa kanseri. Mu Bushinwa, sintilimab yemejwe kandi ishyirwa muri NRDL ivuguruye ku bimenyetso birindwi. Urwego ruvuguruye rwo kwishyura NRDL kuri TYVYT (inshinge ya sintilimab) rurimo:
Kuvura indwara ya Hodgkin's lymphoma yasubiwemo cyangwa idashobora kuvura nyuma yo gufata imiti ya chimiotherapie inshuro ebyiri cyangwa nyuma yayo;
Ku buryo bwa mbere bwo kuvura kanseri y'ibihaha idakira cyangwa idafite EGFR cyangwa ALK idafite EGFR cyangwa ALK;
Kuvura abarwayi barwaye kanseri y'ibihaha ya EGFR yahindutse mu gace runaka cyangwa isanzwe iterwa n'uturemangingo duto tw'ibihaha twakomeje kwiyongera nyuma yo kuvurwa na EGFR-TKI;
Kuvura kanseri y'ibihaha idashobora kuvurwa mu gace runaka cyangwa kanseri y'ibihaha idakira;
Kuvura kanseri y'umwijima idakira cyangwa isanzwe idakira nta buryo bwo kuyivura mbere;
Kuvura kanseri y’uturemangingo tw’umuyoboro w’amaraso idakira, ishobora kugaruka cyangwa yanduye mu buryo bwa kanseri y’umuyoboro w’amaraso;
Kuvura indwara ya adenocarcinoma idakira, ishobora kugaruka cyangwa yanduye mu gace runaka.
Byongeye kandi, ikimenyetso cya munani cya sintilimab, hamwe na fruquintinib mu kuvura abarwayi barwaye kanseri y’inkondo y’umura bafite ibibyimba bya pMMR byananiwe ubuvuzi bw’umubiri mbere kandi batari abakandida bo kubagwa cyangwa kuvurwa hakoreshejwe imirasire, byemejwe na NMPA mu Kuboza 2024.
Byongeye kandi, ubushakashatsi bubiri bwo kwa muganga bwa sintilimab bwageze ku ntego zabwo z'ibanze:
Inyigo y'icyiciro cya kabiri ku buvuzi bwa sintilimab monotherapy nk'uburyo bwa kabiri bwo kuvura kanseri y'uturemangingo two mu ruhu;
Inyigo y'icyiciro cya 3 ku buvuzi bwa sintilimab monotherapy nk'uburyo bwa kabiri bwo kuvura kanseri y'ibihaha itari squamous non-small cell hamwe n'indwara nyuma ya platine-based chemotherapy.
Ibyerekeye Fruquintinib
Fruquintinib ni umuti ugabanya ubukana bw’imitsi itatu itera imitsi gukura (“VEGF”) (VEGFR-1, -2 na -3). Uturinda twa VEGFR tugira uruhare runini mu gukumira angiogenesis ya tumor. Fruquintinib yagenewe kugira ubushobozi bwo guhitamo neza bugabanya imikorere ya kinase idashingiye ku ntego, bigatuma imiti igera ku rwego rwo kugabanya ubukana bw’imitsi no koroshya ikoreshwa mu buryo burambye nk’igice cy’ubuvuzi buvanze.
Fruquintinib yemerewe kugurishwa mu kuvura abarwayi ba kanseri y'inkondo y'umura yateye mbere bahawe fluoropyrimidine, oxaliplatin na chimiotherapie ishingiye kuri irinotecan, hamwe n'ababanje guhabwa cyangwa batakwiriye guhabwa imiti irwanya VEGF cyangwa ubuvuzi burwanya epidermal growth factor receptor ("EGFR") (RAS wild-type) mu Bushinwa, aho yateguwe kandi igahuzwa na HUTCHMED na Eli Lilly and Company ku izina rya ELUNATE. Yashyizwe mu rutonde rw'imiti ikoreshwa mu Bushinwa ku rwego rw'igihugu ("NRDL") muri Mutarama 2020. Kuva yatangizwa mu Bushinwa, abarwayi barenga 100.000 barwaye kanseri y'inkondo y'umura bavuwe na fruquintinib.
Mu Ukuboza 2024, fruquintinib yemejwe na NMPA hamwe na sintilimab mu kuvura abarwayi bafite kanseri y’inkondo y’umura iteye imbere bafite ibibyimba bya pMMR byananiwe ubuvuzi bw’umubiri mbere kandi batari abakandida bo kubagwa cyangwa kuvurwa hakoreshejwe imirasire.
Kugeza ubu, haracyari igeragezwa ryinshi ry’ikoranabuhanga rishya rirwanya kanseri mu Bushinwa rishaka abarwayi. Inama ku miti mishya n’ikoranabuhanga, ushobora kuvugana n’Ishami Mpuzamahanga ry’Ibitaro bya Oncology bya Beijing mu Karere k’Amajyepfo.
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Amareferensi
1.https: //www.nmpa.gov.cn/zwfw/sdxx/sdxxyp/yppjfb/20241203153537120.html
2.https: //cn.innoventbio.com/#/amakuru/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
Igihe cyo kohereza: Ukuboza 16-2024