NMPA Yemeje Trastuzumab Rezetecan (SHR-A1811) kuri HER2-Mutated NSCLC

Ku ya 29 Gicurasi, Ikigo cy’Igihugu gishinzwe Ibikoresho by’Ubuvuzi (NMPA) cyemeje umuti wa HER2-targeted antibody-drug conjugate (ADC) trastuzumab rezetecan (SHR-A1811) kugira ngo ugurishwe. Ugaragazwa nk'uburyo bwo kuvura abarwayi bakuru bafite kanseri y’ibihaha idakira cyangwa idafite utunyangingo duto (NSCLC) bafite impinduka za HER2 (ERBB2) kandi bakaba barahawe nibura ubuvuzi bumwe mbere. Ubu ni bwo buryo bwa mbere bwakozwe n’Ubushinwa bwa ADC bwemewe ku barwayi bafite HER2-mutated NSCLC, butanga uburyo bushya bwo kuvura kuri aba barwayi.

Kwemeza gushingiye ku bushakashatsi bw'ingenzi bwakozwe na HORIZON-Lung, bwayobowe na Porofeseri Lu Shun wo mu bitaro bya Shanghai Chest Hospital.

Inyigo ya HORIZON-Lung ni igerageza ry’ubuvuzi ryakozwe mu byiciro byinshi, rifunguye, riyobowe n’itsinda rya Porofeseri Lu Shun mu bitaro bya Shanghai Chest. Igice cya mbere cyari kigamije kumenya dose ntarengwa yihanganirwa (MTD) ya trastuzumab rezetecan no gusuzuma imikorere yayo y’ibanze n’umutekano wayo ku barwayi bafite HER2-muted NSCLC. Imiterere y’inyigo yari ikubiyemo icyiciro cyo kongera dose n’icyiciro cyo kongera dose. Mu gice cya mbere, trastuzumab rezetecan yagaragaje imikorere y’ibanze yo kurwanya ikibyimba n’umutekano mwiza. Inyigo ya kabiri yari igamije gusuzuma imikorere n’umutekano wa trastuzumab rezetecan ku barwayi bafite HER2-muted NSCLC.

Abarwayi 94 ni bo barangije kwiyandikisha muri ubu bushakashatsi. Ibisubizo byagaragaje ko igipimo cy’ubutabazi bw’ibanze (ORR), nk’uko byagenzuwe na Komite Yigenga Ishinzwe Isuzuma (IRC), cyari 74.5%, aho igipimo cyo kurwanya indwara (DCR) cya 98.9%. Igihe cyo hagati cy’ubutabazi (DoR) cyari amezi 9.8. Isesengura ry’amatsinda rito ryagaragaje ko akamaro ka trastuzumab rezetecan kari gahoraho mu matsinda atandukanye y’abarwayi, hatitawe ku buvuzi bwa mbere bwa anti-HER2 tyrosine kinase inhibitor (TKI) cyangwa kuba hari metastases y’ubwonko.

IRC-assessed progression-free survival (PFS) yagaragaje ko igipimo cya PFS cy’amezi 11.5, aho igipimo cya PFS cy’amezi 12 cya 48.6%. PFS yasuzumwe n’abashakashatsi (INV) yari amezi 12.5, naho igipimo cya PFS cy’amezi 12 cya 51.4%.

Amakuru yose yerekeye ubuzima (OS) ntabwo aragera ku rwego rwo hejuru, aho urwego rw'imikorere (OS) rutaragera ku rwego rwo hejuru kandi igipimo cy'imikorere (OS) mu mezi 12 cya 88.2%.

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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