Ikigo cy'Igihugu gishinzwe Ibikoresho by'Ubuvuzi mu Bushinwa (NMPA) cyemeye VYLOYTM (zolbetuximab) ku buvuzi bwa mbere bwa Adenocarcinoma yo mu gifu cyangwa mu gice cy'igifu

Ku ya 31 Ukuboza, Ikigo cy’Igihugu gishinzwe Ibikoresho by’Ubuvuzi mu Bushinwa (NMPA) cyemeje VYLOYTM (zolbetuximab), hamwe na fluoropyrimidine na platine-containing chemotherapy, mu kuvura abarwayi bafite adenocarcinoma y’agakoko gatera kanseri y’uruhu idashobora kuvurwa cyangwa ikwirakwira mu mubiri (GEJ) ifite HER2 (negative gastric or gastroesophageal junction) ifite ibibyimba bya claudin (CLDN) 18.2. Zolbetuximab ni yo antibody ya mbere yemewe na NMPA yibasira uturemangingo twa kanseri y’agakoko gatera kanseri igaragaza CLDN18.2, itanga uburyo bwo kuvura kanseri bwibanda cyane ku buryo bugezweho.

Kwemeza kwa NMPA zolbetuximab bishyigikiwe n'amakuru yavuye mu bushakashatsi bwa GLOW na SPOTLIGHT ku rwego rw'isi bwari bugizwe n'abarwayi 145 na 36 baturutse mu Bushinwa, uko bikurikirana. Igerageza rya GLOW ryasuzumye zolbetuximab hamwe na CAPOX (uburyo bwo gufata imiti ya chimiotherapie burimo capecitabine na oxaliplatin) ugereranije na placebo hamwe na CAPOX. Igerageza rya SPOTLIGHT ryasuzumye zolbetuximab hamwe na mFOLFOX6 (uburyo bwo gufata imiti burimo oxaliplatin, leucovorin na fluorouracil) ugereranije na placebo hamwe na mFOLFOX6.

Igerageza rya SPOTLIGHT ryasuzumye zolbetuximab hamwe na mFOLFOX6 (uburyo bwo gufata imiti burimo oxaliplatin, leucovorin na fluorouracil) ugereranije na placebo hamwe na mFOLFOX6. Ubuvuzi bwa zolbetuximab bwagaragaye ko butanga iterambere rikomeye mu mibare mu kurokoka kutagira iterambere (PFS) no kubaho muri rusange (OS) ugereranije n'ubundi buvuzi busanzwe bw'imiti ku barwayi bujuje ibisabwa barwaye kanseri yo mu gifu na GEJ. Mu igerageza rya GLOW, PFS y'amezi 8.21 yagezweho hakoreshejwe zolbetuximab hamwe na CAPOX nk'ubuvuzi bwa mbere ugereranyije n'amezi 6.80 hakoreshejwe placebo hamwe na CAPOX. OS y'amezi 14.39 ugereranyije n'amezi 12.16 mu matsinda y'ubuvuzi. Ibisubizo nk'ibi byagaragaye mu igerageza rya SPOTLIGHT, aho PFS yari amezi 10.61 ugereranije n'amezi 8.67, naho OS yari amezi 18.23 ugereranije n'amezi 15.54, hamwe na zolbetuximab hamwe na mFOLFOX6, ugereranije na placebo hamwe na mFOLFOX6. Mu igerageza rya GLOW na SPOTLIGHT, ingaruka mbi zikomeye zo kuvurwa (TEAEs) zari zimwe mu matsinda yavurwaga na zolbetuximab ugereranije n'abayisuzuma. TEAE zikunze kugaragara mu matsinda yavurwaga na zolbetuximab zari isesemi, kuruka no kubura ubushake bwo kurya.

Mu isesengura ryakozwe, ikigereranyo cy’ubuzima butarimo iterambere cyari amezi 9.2 mu itsinda rya zolbetuximab n’amezi 8.2 mu itsinda rya placebo (igipimo cy’ibyago bitewe n’iterambere cyangwa urupfu, 0.71; 95% igihe cy’icyizere [CI], 0.61 kugeza 0.83). Abarwayi 377 muri 537 (70.2%) mu itsinda rya zolbetuximab n’abarwayi 424 muri 535 (79.3%) mu itsinda rya placebo bapfuye. Igipimo cy’ubuzima rusange cyari amezi 16.4 mu itsinda rya zolbetuximab n’amezi 13.7 mu itsinda rya placebo (igipimo cy’ibyago bitewe n’urupfu, 0.77; 95% CI, 0.67 kugeza 0.89). Ubwoko bw’ubuvuzi bwakurikiyeho bwo kurwanya kanseri bwari buringaniye hagati y’amatsinda y’ubuvuzi.

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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INYANDIKO Z'IBIREGO

1.国家药监局批准注射用佐妥昔单抗上市 (nmpa.gov.cn)

2.Zolbetuximab hamwe na CAPOX muri CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma: igerageza rya GLOW ryakozwe ku buryo butaziguye, icyiciro cya 3 | Ubuvuzi bw'Imiterere

3.Zolbetuximab mu gice cy'igifu cyangwa igifu Adenocarcinoma | Ikinyamakuru cya New England Journal of Medicine (nejm.org)

4.Zolbetuximab hamwe na mFOLFOX6 ku barwayi ba CLDN18.2-positive, HER2-negative, batavuwe, bakuze mu gace runaka badafite kanseri y'igifu cyangwa gastro-oesophageal junction (SPOTLIGHT): igerageza rya multicentre, ryakozwe ku buryo butaziguye, ritagaragara, ryibasiwe n'amaso, icyiciro cya 3 – Lancet