Ku ya 20 Ukuboza 2024, Ikigo cy’Igihugu gishinzwe Ibikoresho by’Ubuvuzi mu Bushinwa (NMPA) cyemeje Porogaramu Nshya y’Imiti (NDA) ya DOVBLERON ® (taletrectinib adipate capsule), umuti ugabanya ubukana bwa ROS1 tyrosine kinase inhibitor (TKI) wo mu gisekuru gikurikira, kugira ngo uvurwe abarwayi bakuru bafite kanseri y’ibihaha idakwirakwira mu gace runaka cyangwa ikwirakwira muri ako gace (NSCLC) ya ROS1-positive non-small cell cancer) bamaze kuvurwa na ROS1 TKIs.
Kwemeza gushingiye ku bisubizo byiza byavuye mu igerageza ry’ingenzi rya TRUST-I ry’icyiciro cya 2 (NCT04395677), igerageza ry’urwego runini, rifunguye, rikoresha ukuboko kumwe ryasuzumye taletrectinib ku barwayi b’Abashinwa bafite NSCLC ya ROS1-positive. Ibyavuye mu bushakashatsi, byagaragajwe mu nama ngarukamwaka y’Umuryango w’Abanyamerika w’Ubuvuzi bw’Imiti (ASCO) yo mu 2024 kandi byasohotse mu kinyamakuru Journal of Clinical Oncology (JCO), byagaragaje ubushobozi bwa DOVBLERON® bwo gukemura ibibazo bitaragerwaho, cyane cyane ku barwayi bafite uburyo buke bwo kuvura nyuma yo kuvurwa hakoreshejwe uburyo bwa ROS1 bwabanje.
Ku ya 29 Ugushyingo 2023, abarwayi 173 b'Abashinwa (106 TKI naїve; 67 crizotinib-pretrected) bahawe taletrectinib. Mu barwayi 106 TKI-naїve, cORR yasuzumwe na IRC yari 90.6% (95% CI, 83.33 kugeza 95.38) aho abarwayi bane (3.8%) babonye CR na 92 (86.8%) babonye PR. DCR yari 95.3% (95% CI, 89.33 kugeza 98.45), naho TTR yari amezi 1.4 (95% CI, 1.38 kugeza 1.41). Hamwe n'ikurikirana ry'amezi 22.1 n'amezi 23.5, nta DOR cyangwa PFS yo hagati byagezweho; DOR y'amezi 24 na PFS byari 78.6% (95% CI, 66.86 kugeza 86.56) na 70.5% (95% CI, 59.17 kugeza 79.16), uko bikurikirana.
Mu barwayi 66 bavuwe mbere ya crizotinib, cORR yasuzumwe na IRC yari 51.5% (95% CI, 38.88 kugeza 64.01) aho abarwayi 34 (51.5%) bageze kuri PR. DCR yari 83.3% (95% CI, 72.13 kugeza 91.38), naho TTR yari hagati y'amezi 1.4 (95% CI, 1.38 kugeza 1.41). Hamwe n'amezi 8.4 n'amezi 9.7 yo gukurikiranwa, DOR yari hagati y'amezi 10.6 (95% CI, 6.31 kugeza bitaragera kuri [NR]), naho PFS yari hagati y'amezi 7.6 (95% CI, 5.52 kugeza 11.96). Igipimo cya DOR na PFS cy'amezi 9 cyari 69.8% (95% CI, 47.94 kugeza 83.84) na 47.4% (95% CI, 33.50 kugeza 60.02). Ibisubizo nk'ibyo byagaragaye ubwo abashakashatsi basuzumaga.
Ibyerekeye DOVBLERON ® (Taletrectinib Adipate Capsule)
DOVBLERON ® ni ROS1 yo mu kanwa, ikomeye, ikora ku buryo bw'imikorere y'imitsi yo hagati, itoranya, kandi ikoreshwa mu gihe kizaza.
inhibitor yagenewe by'umwihariko kuvura abarwayi bafite NSCLC ya ROS1-positive. Taletrectinib, ikinyabutabire gikora muri DOVBLERON ® kirimo gusuzumwa kugira ngo kivure abarwayi bafite NSCLC ya ROS1-positive mu bushakashatsi bubiri bw’icyiciro cya kabiri: TRUST-I (NCT04395677) mu Bushinwa, na TRUST-II (NCT04919811), ubushakashatsi mpuzamahanga.
Kanseri y'ibihaha ikomeje kugira umubare munini w'abandura kanseri n'impfu ku isi, aho NSCLC ingana na 85% by'abarwayi bose. Mu Bushinwa, bivugwa ko hafi 2.6% by'abarwayi babana na NSCLC bafite ROS1. Byongeye kandi, metastases mu bwonko ni ikibazo gikunze kugaragara, kigira ingaruka kuri 35% by'abarwayi baherutse gupimwa NSCLC ya ROS1-positive, kandi kiyongera kikagera kuri 55% by'abarwayi bafite kanseri nyuma yo kuvurwa bwa mbere. Byongeye kandi, abarwayi bavuwe na ROS1 TKIs zemewe bakunze kugira impinduka mu buvuzi, bikaba ari imbogamizi ikomeye ku barwayi mu gihe cyo gusubiza. Kwemerwa kwa DOVBLERON® bitanga uburyo bushya kandi bwiza bwo kuvura abarwayi batagisubiza imiti yemewe mbere.
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/zhuanti/cxylqx/cxypxx/20241220172636101.html
2.Itangazo rigenewe abanyamakuru (innoventbio.com)
3.https://ascopubs.org/doi/10.1200/JCO.24.00731?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed
Igihe cyo kohereza: Ukuboza-27-2024