Ku itariki ya 3 Ukuboza 2024, umuti mushya witwa Zepzelca (lurbinectin yo guterwa inshinge) wemejwe n’Ikigo cy’Igihugu cy’Ubushinwa gishinzwe Ibikoresho by’Ubuvuzi (NMPA) binyuze muri gahunda yo gusuzuma ibyihutirwa. Uyu muti ugenewe kuvura abarwayi bakuru barwaye kanseri y’ibihaha ifata uturemangingo duto (SCLC) bafite indwara nyuma yo guhabwa imiti ya platine cyangwa nyuma yayo.
Zepzelca ni umuti ugabanya ubukana bw’imiti iterwa na kanseri. Nubwo ibuza iyi miti gukorerwa na kanseri, igenzura ibidukikije bito ku mikorobe kandi igatera imisemburo y’uturemangingo twa kanseri. Uyu muti kandi wemejwe n’Ikigo gishinzwe ibiribwa n’imiti cya Amerika (FDA) binyuze muri gahunda yacyo yo kwihutisha ubuvuzi mu 2020. Mu myaka 27 ishize, ni wo muti mushya wemewe na FDA mu kuvura SCLC yasubitse kuva mu 1997.
Kwemezwa kwa Zepzelca na NMPA kwashingiye ku byavuye mu bushakashatsi bubiri bwo kwa muganga. Bumwe muri bwo bwari ubushakashatsi bw'ingenzi bwakorewe mu mahanga, inyigo y’icyitegererezo, inyigo y’itsinda ry’abantu benshi, n’inyigo y’itsinda rimwe (igerageza ryakozwe mu cyiciro cya 2) ku barwayi bakuru barwaye SCLC (harimo abarwayi bafite platine n’abadakira platine) bahuye n’ingaruka z’indwara nyuma yo guhabwa imiti ishingiye kuri platine. Muri ubu bushakashatsi, bavuwe na Zepzelca yonyine binyuze mu gutera umuti mu mitsi buri byumweru 3 ku gipimo cya 3.2 mg/m2. Ubu bushakashatsi bwasohotse mu kinyamakuru The Lancet Oncology, cyagaragaje ko igipimo rusange cy’ubutabazi (ORR) cya 35.2%, igipimo cy’igihe cyo gusubiza (mDoR) cy’amezi 5.3, igipimo cy’igihe cyo kubaho kidahinduka (mPFS) cy’amezi 3.5, na mOS y’amezi 9.3 ku barwayi bose bavuwe na Zepzelca. Ubundi bushakashatsi bwakozwe ku ruhande rumwe, buhuza uburyo Zepzelca yakoreshejwe mu kongera no kwagura urugero rw'umuti ikoreshwa mu kuvura indwara kugira ngo harebwe umutekano wayo, ubushobozi bwo kwihanganira indwara, uburyo ikoreshwa mu kuvura indwara (PK), n'ubushobozi bwayo bw'ibanze ku barwayi b'Abashinwa bafite ibibyimba bikomeye, harimo na SCLC isubiramo. Ubushakashatsi bwagaragaje ko ORR ya 45.5%, mDoR ya mezi 4.2, mPFS ya mezi 5.6 na mOS ya mezi 11.0 ku barwayi ba SCLC bavuwe na Zepzelca binyuze mu gutera imiti mu mitsi buri byumweru 3 ku gipimo cya 3.2 mg/m2.
Ubushakashatsi bubiri bwavuzwe haruguru bwagaragaje ko Zepzelca irwanya kanseri cyane nk'uburyo bwa kabiri bwo kuvura SCLC bufite umutekano uhagije. Byongeye kandi, ubushakashatsi bwakorewe mu baturage b'Abashinwa bwagaragaje ko abarwayi barushaho kugira ingaruka nziza.
Byongeye kandi, Zepzelca irimo gukorwaho ubushakashatsi mu magerageza menshi mpuzamahanga y’ubuvuzi. Mu nyigo yakozwe mu cyiciro cya 1/2, Zepzelca hamwe na atezolizumab byagaragaje ORR ya 66.67%, mPFS ya mezi 4.7, na mOS ya mezi 14.5 iyo bikoreshejwe nk'ubuvuzi bwa kabiri ku barwayi bafite SCLC y’icyiciro kinini. Mu nyigo yakozwe mu cyiciro cya 1/2, Zepzelca yahuje na pembrolizumab yagaragaje ORR ya 46.4%, mPFS ya mezi 5.3, na mOS ya mezi 11.1 nk'ubuvuzi bwa kabiri ku barwayi bafite SCLC yasubiwemo. Byongeye kandi, inyigo z’ubuvuzi zirimo Zepzelca hamwe n’umuti urinda ubudahangarwa bw’umubiri nk'uburyo bwa mbere bwo kuvura SCLC, hamwe na chimiotherapie yo kuvura SCLC yasubiwemo, ndetse no kuvura leiomyosarcoma nazo zirakomeje. Ubu bushakashatsi bugamije gukomeza gusuzuma ikoreshwa ry’uyu muti mu buvuzi n’ubushobozi bwo kuvura.
Kugeza ubu, Zepzelca yemerewe kugurishwa mu bihugu 17 n'uturere ku isi. Luye Pharma yahawe uburenganzira bwo guteza imbere no gucuruza uyu muti mu Bushinwa, Hong Kong, na Macao, kandi yahawe uburenganzira bwo kugurishwa uyu muti muri utu turere dutatu.
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.
Nimero ya Terefone: 4008803716
Email：myimmnet@163.com
Amareferensi
1.2024 年 12 月 03 日药品批准证明文件送达信息 (nmpa.gov.cn)
2.绿叶制药宣布治疗小细胞肺癌创新药赞必佳® （注射用芦比替定）获得国家药品监督管理局上市批准 - 新闻动态 - 绿叶 - 绿叶制药集团 (luye.cn)
Igihe cyo kohereza: Mutarama 14-2025