Ku itariki ya 29 Kanama, imiti ya Boehringer Ingelheim's HERNEXEOS® (ibinini bya zongertinib) yemejwe nk'umuti umwe n'Ikigo cy'Igihugu cy'Ubuvuzi mu Bushinwa (NMPA) mu kuvura abarwayi bakuru bafite kanseri y'ibihaha idakira, iteye imbere cyangwa isanzwe idafata uturemangingo duto (NSCLC) bafite ibibyimba bifite impinduka za HER2 (ERBB2) kandi bakaba barahawe nibura umurongo umwe w'ubuvuzi bwabanje.
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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Kwemererwa gushingiye ku makuru yavuye mu igerageza rya Phase Ib Beamion-LUNG 1 (NCT04886804): Igerageza ryo kongera urugero rw'umuti wa Phase I, ryemeza kandi rikongera urugero rw'umuti wa zongertinib nk'umuti umwe ku bantu bafite ibibyimba bikomeye bidakira cyangwa bifite impinduka za HER2. Ubu bushakashatsi bufite ibice 2. Igice cya mbere gifunguye ku bantu bakuru bafite ubwoko butandukanye bwa kanseri ikomeye ifite impinduka za HER2 zirimo impinduka za HER2, kwiyongera, gutanga ibimenyetso bikabije no guhuza imikorere y'imiti mbere y'uko ubuvuzi bwabo butagenze neza. Igice cya kabiri gifunguye ku bantu bafite kanseri y'ibihaha itari ndende ya HER2.
Mu itsinda rya 1, abarwayi 75 bose hamwe bahawe zongertinib ku gipimo cya 120 mg. Mu gihe cyo gusesengura amakuru (ku ya 29 Ugushyingo 2024), 71% by'aba barwayi (95% igihe cy'icyizere [CI], 60 kugeza 80; P<0.001 ugereranije n'igipimo cya ≤30%) bari bafite igisubizo cyemewe; igihe cyo hagati cy'igisubizo cyari amezi 14.1 (95% CI, 6.9 kugeza bitapimwe), naho igihe cyo hagati cy'ubuzima budafite iterambere cyari amezi 12.4 (95% CI, 8.2 kugeza bitapimwe). Indwara mbi zikomoka ku miti zo mu cyiciro cya 3 cyangwa hejuru zabaye ku barwayi 13 (17%). Mu itsinda rya 5 (abarwayi 31), 48% by'abarwayi (95% CI, 32 kugeza 65) bari bafite igisubizo cyemewe. Indwara mbi zikomoka ku miti zo mu cyiciro cya 3 cyangwa hejuru zabaye ku murwayi 1 (3%). Mu itsinda rya 3 (abarwayi 20), 30% by'abarwayi (95% CI, 15 kugeza 52) bagaragaje ko bagaragaje ko nta kibazo. Ingaruka mbi zikomoka ku miti zo mu cyiciro cya 3 cyangwa hejuru zagaragaye ku barwayi 5 (25%). Muri ayo matsinda yose uko ari atatu, nta cyorezo cy'indwara y'ibihaha iterwa n'imiti cyabayeho.
“Birashimishije kubona uburyo NMPA ikomeje kugaragaza ubushobozi bwa zongertinib. Uburyo bwo kuvura bwa mbere bwo gukoresha zongertinib mu Bushinwa bugaragaza ko abarwayi bakeneye ubufasha bwihutirwa. Ni intambwe ikomeye yo gutuma ubu buvuzi buboneka ku barwayi benshi babukeneye,” ibi ni ibyatangajwe na Shashank Deshpande, Perezida w’Inama y’Ubuyobozi muri Boehringer Ingelheim.
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
Indangamuntu ya WeChat: 17801183037
Email：myimmnet@163.com
Igihe cyo kohereza: Nzeri-02-2025