Maamulka Badeecadaha Caafimaadka Qaranka ee Shiinaha (NMPA) ayaa ansixiyay VYLOYTM (zolbetuximab) si loogu daaweeyo kansarka caloosha ama mindhicirka ee heerka sare ah.

Diseembar 31, Maamulka Badeecadaha Caafimaadka Qaranka ee Shiinaha (NMPA) ayaa ansixiyay VYLOYTM (zolbetuximab), oo ay weheliso kiimoterabiga fluoropyrimidine iyo platinum-ka ku jira, si loogu daaweeyo bukaanka qaba adenocarcinoma-ga caloosha ama caloosha oo aan la tirtiri karin ama metastatic ah (HER2) oo ah nooca kansarka caloosha ama caloosha oo burooyinka ay yihiin claudin (CLDN) 18.2 positive. Zolbetuximab waa antibody-ga monoclonal ee ugu horreeya ee NMPA ay ansixisay ee bartilmaameedsada unugyada burooyinka caloosha ee muujiya calaamadda CLDN18.2, isagoo bixinaya hab aad loogu bartilmaameedsado daaweynta kansarka.

Ansixinta NMPA ee zolbetuximab waxaa taageeraya xog laga helay tijaabooyinka caafimaad ee Wejiga 3aad ee GLOW iyo SPOTLIGHT oo ay ku jiraan 145 iyo 36 bukaan oo ka yimid dhul-weynaha Shiinaha, siday u kala horreeyaan. Tijaabada GLOW waxay qiimaysay zolbetuximab iyo CAPOX (nidaam isku-dhafan oo kiimoterabi ah oo ay ku jiraan capecitabine iyo oxaliplatin) marka la barbar dhigo placebo iyo CAPOX. Tijaabada SPOTLIGHT waxay qiimaysay zolbetuximab iyo mFOLFOX6 (nidaam isku-dhafan oo ay ku jiraan oxaliplatin, leucovorin iyo fluorouracil) marka la barbar dhigo placebo iyo mFOLFOX6.

Tijaabada SPOTLIGHT waxay qiimeysay zolbetuximab iyo mFOLFOX6 (nidaam isku dhafan oo ay ku jiraan oxaliplatin, leucovorin iyo fluorouracil) marka la barbar dhigo placebo iyo mFOLFOX6. Daaweynta zolbetuximab waxaa la muujiyay inay bixiso horumar tirakoob ahaan muhiim ah oo ku saabsan badbaadada aan horumarka lahayn (PFS) iyo badbaadada guud (OS) marka la barbar dhigo heerarka kale ee daaweynta kiimoterabiga ee bukaanada u qalma ee qaba kansarka caloosha iyo GEJ. Tijaabada GLOW, PFS dhexdhexaad ah oo 8.21 bilood ah ayaa lagu gaaray zolbetuximab iyo CAPOX oo ah daaweyn safka hore ah marka la barbar dhigo 6.80 bilood oo leh placebo iyo CAPOX. OS dhexdhexaad ah wuxuu ahaa 14.39 bilood marka loo eego 12.16 bilood kooxaha daaweynta ee kala duwan. Natiijooyin wax ku ool ah oo la mid ah ayaa lagu arkay tijaabada SPOTLIGHT, halkaas oo dhexdhexaadka PFS uu ahaa 10.61 bilood marka loo eego 8.67 bilood, dhexdhexaadka OS-na wuxuu ahaa 18.23 bilood marka loo eego 15.54 bilood, iyadoo zolbetuximab iyo mFOLFOX6, marka la barbar dhigo placebo iyo mFOLFOX6. Labada tijaabo ee GLOW iyo SPOTLIGHT, dhacdooyinka dhacdooyinka daaweynta halista ah ee soo noqnoqda (TEAEs) waxay la mid ahaayeen kooxaha daaweynta zolbetuximab marka loo eego kantaroolka. TEAE-yada ugu badan ee laga soo sheegay kooxaha daaweynta zolbetuximab waxay ahaayeen lallabbo, matag iyo rabitaan cunto oo yaraaday.

Falanqaynta isku dhafan, badbaadada dhexdhexaadka ah ee aan horumarka lahayn waxay ahayd 9.2 bilood kooxda zolbetuximab iyo 8.2 bilood kooxda placebo (saamiga khatarta ee horumarka ama dhimashada, 0.71; 95% muddada kalsoonida [CI], 0.61 ilaa 0.83). Wadarta guud ee 377 ka mid ah 537 bukaan (70.2%) kooxda zolbetuximab iyo 424 ka mid ah 535 bukaan (79.3%) kooxda placebo ayaa dhimatay. Celceliska badbaadada guud waxay ahayd 16.4 bilood kooxda zolbetuximab iyo 13.7 bilood kooxda placebo (saamiga khatarta dhimashada, 0.77; 95% CI, 0.67 ilaa 0.89). Noocyada daawaynta ka hortagga kansarka ee xigay ayaa la isku dheellitiray kooxaha daaweynta.

Waqtigan xaadirka ah, waxaa weli jira tijaabooyin caafimaad oo badan oo ku saabsan teknoolojiyada cusub ee ka hortagga kansarka ee Shiinaha oo raadinaya bukaanno. La-tashi ku saabsan daawooyinka cusub iyo teknoolojiyada, waxaad la xiriiri kartaa Waaxda Caalamiga ah ee Isbitaalka Oncology ee Gobolka Koonfureed ee Beijing.

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TIXRAACYADA

1.国家药监局批准注射用佐妥昔单抗上市 (nmpa.gov.cn)

2.Zolbetuximab iyo CAPOX oo ku jira CLDN18.2-positive caloosha ama isgoyska caloosha iyo mindhicirka adenocarcinoma: tijaabada aan la kala soocin, wejiga 3 ee GLOW | Dabiiciga Daawada

3.Zolbetuximab oo ku jira Isgoyska Caloosha ama Xididdada Gastric Adenocarcinoma | Joornaalka Daawada ee New England (nejm.org)

4.Zolbetuximab iyo mFOLFOX6 ee bukaanada qaba CLDN18.2-positive, HER2-negative, aan la daaweyn, oo heer deegaan ah oo aan la tirtiri karin ama metastatic gastric ama gastro-oephageal junction adenocarcinoma (SPOTLIGHT): tijaabo badan oo xarun ah, oo aan kala sooc lahayn, laba-indhoole ah, marxaladda 3aad - The Lancet