Anti-PD-L1 (Tagitanlima) yahawe uburenganzira bwa NMPA bwo kwamamaza

Ku ya 31 Ukuboza 2024, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Isosiyete") yahawe uburenganzira bwo kwamamaza mu Bushinwa n'Ikigo cy'Igihugu gishinzwe Ibikoresho by'Ubuvuzi (NMPA) ku muti w’uturemangingo duto twateguwe na programmed cell death ligand1 (PD-L1) (“mAb”) tagitanlimab (yahoze ari KL-A167) (科泰莱®) wo kuvura abarwayi barwaye kanseri yo mu nda isubira cyangwa itera kanseri (NPC) yananiranye nyuma y’imiti ya 2L+ mbere. Uyu ni wo muti wa mbere ku isi wa PD-L1 monoclonal antibody wemejwe mu kuvura NPC.

Kwemeza gushingiye ku bushakashatsi bwakozwe ku barwayi barwaye indwara ya NPC isubira cyangwa ya metastatic bananiwe nyuma yo kuvura indwara ya 2L+, buyobowe na Porofeseri Shi Yuankai wo mu bitaro bya Cancer Hospital Chinese Academy of Medical Sciences nk'umushakashatsi mukuru, kugira ngo basuzume imikorere n'umutekano wa tagitanlimab monotherapy.

Hagati ya 26 Gashyantare 2019 na 13 Mutarama 2021, abarwayi 153 baravuwe. Muri rusange, abarwayi 132 binjiye mu isesengura ryuzuye (FAS) kandi bapimwe niba barabikoze neza. Ku itariki yo kurangiza amakuru ku ya 13 Nyakanga 2021, igihe cyo gukurikirana cyari amezi 21.7 (95%CI 19.8–22.5). Ku baturage ba FAS, ORR yasuzumwe na IRC yari 26.5% (95%CI 19.2–34.9%), naho igipimo cyo kurwanya indwara (DCR) cyari 56.8% (95%CI 47.9–65.4%). Kurokoka hagati y’amezi 2.8 (95%CI 1.5–4.1). Igihe cy’igisubizo cyari amezi 12.4 (95%CI 6.8–16.5), naho igihe cy’impinduka mu mibereho rusange (OS) cyari amezi 16.2 (95%CI 13.4–21.3).

Ku bijyanye na NPC

Imibare ya GLOBOCAN yo mu 2022 yagaragaje ko hari abantu barenga 120.000 barwaye kanseri yo mu nda ku isi, abantu bashya 51.000 barwaye kanseri yo mu nda n'impfu 28.400 mu Bushinwa. Dukurikije amabwiriza ya CSCO yo mu 2021, uburyo bwo kuvura kanseri yo mu nda ya 1L idakira cyangwa ivurwa mu gace runaka bushingiye ku miti ivanze irimo platine, naho ubuvuzi bwa 2L bushingiye ku buvuzi bumwe. Igipimo cy'ubuzima bw'abarwayi barwaye kanseri yo mu nda ya 1L isubira cyangwa ivurwa mu maraso ni 18.5%, aho ikigereranyo cy'amezi 22.1, kandi haracyakenewe ko habaho kunoza inyungu z'itsinda ry'abarwayi, cyane cyane abarwara kanseri nyuma yo kuvurwa. Mu myaka ya vuba aha, ubuvuzi bw'ubudahangarwa bw'umubiri bwatanze uburyo bwinshi bwo kuvura abarwayi ba kanseri kandi bwabaye uburyo bwiza bwo kuvura abarwayi ba kanseri yo mu nda.

Ibyerekeye Tagitanlima

Tagitanlima, yakozwe na Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (Chengdu, Ubushinwa), ni antibody ya IgG1κ monoclonal yuzuye igamije kurwanya PD-L1 ibuza imikoranire ya PD-L1 na PD-1.

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.Umuyoboro w'ikoranabuhanga n'ibicuruzwa – Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

2.国家药监局批准塔戈利单抗注射液上市 (nmpa.gov.cn)

3.Ingufu n'umutekano bya KL-A167 muri kanseri yo mu nda yavuwe mbere cyangwa yavuwe mbere: ubushakashatsi bwakozwe mu byiciro byinshi, ukuboko kumwe, icyiciro cya 2 – Ubuzima bw'Akarere bwa Lancet – Western Pacific

4.Chen YP, Chan ATC, Le QT, Blanchard P, Sun Y, Ma J. Kanseri yo mu mazuru. Lancet (London, Ubwongereza) 2019;394(10192):64–80. doi: 10.1016/S0140-6736(19)30956-0.