Musi wa28 Nyamavhuvhu, Center for Drug Evaluation (CDE) yeNational Medical Products Administration (NMPA) yakazivisa kuti mushonga weBL-B01D1 wekubaiwa jekiseni unokurudzirwa kuti ubatanidzwe muongororo yekutanga. Wakagadzirirwa varwere vane chirwere chekenza chemudumbu chinodzoka kana kuti chakapararira, avo vakamborapwa nePD-1/PD-L1 monoclonal antibodies uye vakakundikana kurapwa nechemotherapy kanenge kaviri (nemutsara mumwe chete une platinum).
Parizvino, kuchine miedzo yakawanda yekiriniki yehunyanzvi hutsva hwekurwisa gomarara muChina huri kutsvaga varwere. Kana muchida kubvunzana nezvemishonga mitsva netekinoroji, munogona kubata Dhipatimendi reBeijing South Region Oncology Hospital International.
Nhamba yefoni: 4008803716
Nhamba yeWeChat: 17801183037
Email：myimmnet@163.com
iza-bren iADC yekutanga mukirasi inoumbwa neEGFR x HER3 bispecific antibody yakabatana netopo-I inhibitor payload (Ed-04) kuburikidza ne stable tetrapeptide-based cleavable linker. Maitiro maviri eIza-bren ekuita anovhara zviratidzo zveEGFR neHER3 kumasero ekenza, zvichideredza kuwanda uye zviratidzo zvekurarama. Pamusoro pezvo, kana antibody yaiswa mukati, payadhi yekurapa yeiza-bren inoburitswa zvichikonzera kushushikana kwe genotoxic izvo zvinotungamira kurufu rwemasero ekenza.
Zvakabuda muBL-B01D1 muvarwere vane kenza yemapapu isiri diki (NSCLC) iri panzvimbo yakakwira kana kuti ine shanduko mumasero madiki emapapu (GA) kunze kwekuchinja kweEGFR kwakataurwa paMusangano weGore negore we2025 weAmerican Society of Clinical Oncology (ASCO).
Nzira: Chikamu chechikamu chekudzidza uku chaisanganisira mapoka ekuwedzera, rimwe nerimwe rakatsanangurwa neGA yakatsanangurwa kare, kusanganisira EGFR exon 20 insertions, non-classical EGFR mutations, mutations muHER2, ALK, ROS1, BRAF (V600E nedzimwe), KRAS (G12C nedzimwe), SMARCA4, MET (Exon 14), RET, uye NTRK. Mapoka ane aya GA akafambira mberi pakurapa kwakatarwa (kana kuripo) uye hapana anopfuura mumwe chete wechemotherapy akanyoreswa. iza-bren yakapihwa pa2.5 mg/kg D1D8 Q3W.
Mhedzisiro: Kubva musi wa5 Zvita, 2024, huwandu hwevanhu 73 vane NSCLC vane GA dzakanyorwa vakanyoreswa. Vanhu vashanu vakanga vachiri kurapwa, asi vakabviswa muongororo nekuda kwekusakwana kwekutevera kwekutanga mushure mekutanga (ona tafura iri pazasi). Pakati pevanhu 7 vane EGFR exon 20 insertions, 85.7% (6 kubva pa7) vakawana cPR. Pakati pevanhu 8 vane KRAS G12C mutations, 3 cPR uye 1 PR yakamirira kusimbiswa kwakaonekwa. Kushanda zvakanaka kwemapoka madiki kucharatidzwa. Ma TRAE anowanzo shandiswa muropa (magiredhi ese) aive anemia (87.7%), leukopenia (74.0%), thrombocytopenia (74.0%), uye neutropenia (72.6%); MaTRAE asingawanzoitiki eropa anowanzoonekwa aive asthenia (42.5%), kuda kurutsa (41.1%), stomatitis (37.0%), manyoka (32.9%), uye alopecia (31.5%). MaTRAE eGiredhi 3 zvichikwira ayo aive akawanda eropa, akakwanisa kurapwa zvinobudirira nematanho ekutsigira anosanganisira kuderedza dose, sezvakaratidzwa neTRAE zvichiita kuti huwandu hwekurega kubatwa huve 2.7%. Murwere mumwe chete weG2 ILD akaonekwa. Zvinonyanya kukosha kuti hapana rufu rwakabatana neiza-bren rwakataurwa. Hapana zviratidzo zvitsva zvekuchengetedza zvakaonekwa.
Parizvino, kuchine miedzo yakawanda yekiriniki yehunyanzvi hutsva hwekurwisa gomarara muChina huri kutsvaga varwere. Kana muchida kubvunzana nezvemishonga mitsva netekinoroji, munogona kubata Dhipatimendi reBeijing South Region Oncology Hospital International.
Nhamba yefoni: 4008803716
Nhamba yeWeChat: 17801183037
Email：myimmnet@163.com
Nguva yekutumira: Gunyana-05-2025