Kwemezwa kwa NMPA kwa Limertinib, EGFR TKI yo mu gisekuru cya gatatu mu kuvura kanseri y'ibihaha ku rwego rwa mbere

Ku itariki ya 25 Mata 2025, Innovent Biologics yatangaje ko Ikigo cy’Igihugu gishinzwe Ibikoresho by’Ubuvuzi mu Bushinwa (NMPA) cyemeje Porogaramu Nshya y’Imiti (NDA) ya limertinib nk’uburyo bwa mbere bwo kuvura abarwayi bakuru bafite kanseri y’ibihaha idakomeye cyangwa isanzwe (NSCLC) ifite EGFR exon 19 deletions cyangwa exon 21 L858R mutations.

Limertinib ni EGFR TKI yo mu gisekuru cya gatatu itangwa mu kanwa, ifite uburenganzira ku mutungo wayo. Yemejwe na NMPA y'Ubushinwa ku bijyanye no kuvura abarwayi bakuru bafite kanseri y'ibihaha ya EGFR T790M yahinduwe mu gace runaka (NSCLC), babanje kugira indwara mu gihe cyo kuvurwa cyangwa nyuma yaho hakoreshejwe EGFR TKI; na 2) kuvura abarwayi bakuru ba mbere bafite NSCLC yazamutse cyangwa yahindutse mu gace runaka ifite EGFR exon 19 deletions cyangwa exon 21 L858R mutations.

Kwemezwa kw'iki kimenyetso gishya bishyigikiwe n'ibyavuye mu igerageza ryakozwe ku rwego rwa gatatu rw'ubuvuzi ryakozwe ku buryo butaziguye, budafite ubumuga, kandi bugenzurwa neza. Abarwayi 337 badafite ubuvuzi bafite EGFR-sensitive mutating NSCLC basanzwe cyangwa banduye bashyizwe mu byiciro bitandukanye ku buryo butaziguye kandi bahabwe limertinib cyangwa gefitinib ku rugero rwa 1:1. Ingaruka nyamukuru yari ukurokoka ku buryo butari bwo (PFS), nk'uko byemejwe na komite yigenga ishinzwe isuzuma (IRC).

Imibare yagaragaje ko limertinib yafashe igihe kinini cyane hagati ya PFS ugereranije na gefitinib (amezi 20.7 ugereranije n'amezi 9.7), bigaragaza ko ibyago byo kwiyongera cyangwa gupfa byagabanutseho 56% (igipimo cy'ibyago [HR] 0.44; 95% CI: 0.34–0.58; p < 0.0001). Ku barwayi bafite ibisebe byo mu bwonko (CNS) ku ikubitiro, hagati ya CNS PFS nayo yari ndende cyane hamwe na limertinib (amezi 20.7 ugereranyije n'amezi 7.1), bingana no kugabanuka kwa 72% kw'ibyago byo kwiyongera cyangwa gupfa kwa CNS (HR 0.28; 95% CI: 0.10–0.82; p = 0.0136), bishimangira imikorere yayo ikomeye mu mutwe n'akamaro k'ubuvuzi muri abo bantu bafite ibyo bakeneye byinshi.

Imiterere y'umutekano wa limertinib yari ihuye n'iy'ubuvuzi buzwi bwa EGFR. Ingaruka mbi zari nyinshi zoroheje kugeza ku ziciriritse kandi zihanganirwa neza, nta bimenyetso bishya by'umutekano byagaragaye mu igerageza ry'ubuvuzi. Amakuru yose n'isesengura ry'ubu bushakashatsi bw'ingenzi bw'icyiciro cya 3 bizatangazwa mu binyamakuru by'ubushakashatsi.

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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