Ka la 31 Tšitoe, Tsamaiso ea Lihlahisoa tsa Bongaka ea Naha ea Chaena (NMPA) e amohetse VYLOYTM (zolbetuximab), hammoho le chemotherapy e nang le fluoropyrimidine le platinum, bakeng sa kalafo ea pele ea bakuli ba nang le adenocarcinoma ea gastric kapa gastroesophageal junction (GEJ) e sa senyeheng kapa e sa senyeheng ea batho ba nang le lihlahala tse nang le claudin (CLDN) 18.2 positive. Zolbetuximab ke antibody ea pele ea monoclonal e amohetsoeng ke NMPA ho shebana le lisele tsa hlahala ea gastric tse hlahisang biomarker ea CLDN18.2, e fanang ka mokhoa o shebaneng haholo le kalafo ea kankere.
Kamohelo ea NMPA ea zolbetuximab e tšehetsoa ke lintlha tse tsoang litekong tsa kliniki tsa Mokhahlelo oa 3 oa GLOW le SPOTLIGHT tse neng li kenyelletsa bakuli ba 145 le ba 36 ba tsoang Chaena e kholo, ka ho latellana. Teko ea GLOW e ile ea hlahloba zolbetuximab hammoho le CAPOX (mokhoa oa kalafo ea chemotherapy o kopanyelletsang capecitabine le oxaliplatin) ha e bapisoa le placebo hammoho le CAPOX. Teko ea SPOTLIGHT e ile ea hlahloba zolbetuximab hammoho le mFOLFOX6 (mokhoa oa phekolo o kopanyelletsang oxaliplatin, leucovorin le fluorouracil) ha e bapisoa le placebo hammoho le mFOLFOX6.
Teko ea SPOTLIGHT e hlahlobile zolbetuximab hammoho le mFOLFOX6 (mokhoa o kopaneng o kenyeletsang oxaliplatin, leucovorin le fluorouracil) ha e bapisoa le placebo hammoho le mFOLFOX6. Kalafo ka zolbetuximab e bontšitsoe e fana ka lintlafatso tse bohlokoa ka lipalo-palo ho pholoheng ntle le tsoelo-pele (PFS) le ho phela ka kakaretso (OS) ha e bapisoa le mekhoa e meng ea phekolo ea lik'hemik'hale ho bakuli ba tšoanelehang ba nang le mofetše oa mpa le oa GEJ. Tekong ea GLOW, PFS e mahareng ea likhoeli tse 8.21 e fihletsoe ka zolbetuximab hammoho le CAPOX e le kalafo ea pele khahlano le likhoeli tse 6.80 ka placebo hammoho le CAPOX. OS e mahareng e bile likhoeli tse 14.39 khahlano le likhoeli tse 12.16 lihlopheng tse amehang tsa kalafo. Liphetho tse tšoanang tsa katleho li bonoe tekong ea SPOTLIGHT, moo PFS e mahareng e neng e le likhoeli tse 10.61 ha e bapisoa le likhoeli tse 8.67, 'me OS e mahareng e ne e le likhoeli tse 18.23 ha e bapisoa le likhoeli tse 15.54, ka zolbetuximab hammoho le mFOLFOX6, ha e bapisoa le placebo hammoho le mFOLFOX6. Litekong tsa GLOW le SPOTLIGHT, liketsahalo tsa liketsahalo tse mpe tse mpe tse hlahang kalafong e tebileng (TEAEs) li ne li tšoana lihlopheng tsa kalafo ea zolbetuximab ha li bapisoa le tsa taolo. Li-TEAE tse tloaelehileng haholo tse tlalehiloeng lihlopheng tsa kalafo ea zolbetuximab e ne e le ho nyekeloa ke pelo, ho hlatsa le ho fokotseha ha takatso ea lijo.
Tlhahlobong e kopaneng, ho phela ntle le ho tsoela pele e ne e le likhoeli tse 9.2 sehlopheng sa zolbetuximab le likhoeli tse 8.2 sehlopheng sa placebo (karolelano ea kotsi bakeng sa ho tsoela pele kapa lefu, 0.71; 95% nako ea kholiseho [CI], 0.61 ho isa ho 0.83). Kakaretso ea bakuli ba 377 ho ba 537 (70.2%) sehlopheng sa zolbetuximab le bakuli ba 424 ho ba 535 (79.3%) sehlopheng sa placebo ba shoele. Karolelano ea ho phela ka kakaretso e ne e le likhoeli tse 16.4 sehlopheng sa zolbetuximab le likhoeli tse 13.7 sehlopheng sa placebo (karolelano ea kotsi bakeng sa lefu, 0.77; 95% CI, 0.67 ho isa ho 0.89). Mefuta ea mekhoa ea phekolo e latelang ea ho loantša kankere e ne e leka-lekanngoa lipakeng tsa lihlopha tsa kalafo.
Hona jwale, ho ntse ho na le diteko tse ngata tsa bongaka tsa mahlale a matjha a ho lwantsha kankere Chaena a batlang bakudi. Dipuisano mabapi le meriana le mahlale a matjha, o ka ikopanya le Lefapha la Matjhaba la Sepetlele sa Oncology sa Beijing Region South.
Nomoro ea mohala: 4008803716
Email：myimmnet@163.com
LITŠUPISO
1.国家药监局批准注射用佐妥昔单抗上市 (nmpa.gov.cn)
Nako ea poso: Pherekhong-09-2025