A ranar 28 ga Agusta, Cibiyar Kimanta Magunguna (CDE) ta Hukumar Kayayyakin Lafiya ta Ƙasa (NMPA) ta sanar da cewa an gabatar da shawarar a haɗa BL-B01D1 don allura a cikin tsarin bita na fifiko. An yi shi ne ga marasa lafiya da ke fama da cutar kansa ta nasopharyngeal da ta sake dawowa ko kuma ta bazuwa waɗanda aka yi musu magani da ƙwayoyin rigakafi na monoclonal na PD-1/PD-L1 kuma sun gaza aƙalla layuka biyu na chemotherapy (tare da aƙalla layi ɗaya da ke ɗauke da platinum).
A halin yanzu, har yanzu akwai gwaje-gwaje da yawa na asibiti na sabbin fasahohin yaƙi da cutar kansa a China waɗanda ke neman marasa lafiya. Tuntuɓi kan sabbin magunguna da fasahohi, zaku iya tuntuɓar Sashen Ƙasa da Ƙasa na Asibitin Oncology na Yankin Kudu na Beijing.
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Email：myimmnet@163.com
iza-bren wani nau'in ADC ne na farko da ya ƙunshi wani nau'in antibody mai siffar EGFR x HER3 wanda aka haɗa shi da sabon nau'in topo-I inhibitor payload (Ed-04) ta hanyar haɗin tetrapeptide mai karko. Tsarin aiki guda biyu na Iza-bren yana toshe siginar EGFR da HER3 zuwa ƙwayoyin cutar kansa, yana rage yaɗuwa da siginar tsira. Bugu da ƙari, bayan an haɗa ƙwayoyin cuta cikin jiki, ana sakin nauyin maganin iza-bren wanda ke haifar da damuwa mai guba wanda ke haifar da mutuwar ƙwayoyin cutar kansa.
An gabatar da sakamakon BL-B01D1 a cikin marasa lafiya da ke fama da cutar kansar huhu ta hanyar da ba ta da ƙarfi ko kuma ta hanyar ƙwayoyin cuta marasa ƙanana (NSCLC) waɗanda ke ɗauke da canje-canje a cikin kwayoyin halitta (GA) a wajen maye gurbi na EGFR na gargajiya a taron shekara-shekara na American Society of Clinical Oncology (ASCO) na 2025.
Hanyoyi: Wani ɓangare na wannan binciken ya haɗa da ƙungiyoyin faɗaɗawa, kowannensu an ayyana shi ta hanyar GA da aka riga aka ƙayyade, gami da shigar da EGFR exon 20, maye gurbi na EGFR marasa gargajiya, maye gurbi a cikin HER2, ALK, ROS1, BRAF (V600E da sauransu), KRAS (G12C da sauransu), SMARCA4, MET (Exon 14), RET, da NTRK. An yi amfani da waɗannan GA waɗanda suka ci gaba a kan hanyoyin magancewa na yau da kullun (idan akwai) kuma ba a yi amfani da fiye da layin chemotherapy ɗaya a baya ba. An ba da iza-bren a 2.5 mg/kg D1D8 Q3W.
Sakamako: Ya zuwa ranar 5 ga Disamba, 2024, an yi rijistar jimillar maki 73 na NSCLC tare da GA da aka lissafa. Har yanzu ana kan magani, amma an cire su daga binciken saboda rashin cikakken bin diddigin gwajin farko bayan tushe (duba teburin da ke ƙasa). Daga cikin maki 7 tare da saka EGFR exon 20, kashi 85.7% (6 cikin 7) sun sami cPR. Daga cikin maki 8 tare da maye gurbin KRAS G12C, an lura da cPR 3 da PR 1 da ke jiran a tabbatar. Za a gabatar da inganci ga ƙananan ƙungiyoyi. TRAEs mafi yawan jini (dukkan maki) sune anemia (87.7%), leukopenia (74.0%), thrombocytopenia (74.0%), da neutropenia (72.6%); TRAEs da ba su shafi jini ba sun fi yawa sune asthenia (42.5%), tashin zuciya (41.1%), stomatitis (37.0%), gudawa (32.9%), da alopecia (31.5%). TRAEs na aji na 3 zuwa sama waɗanda galibi suna da alaƙa da jini, an iya sarrafa su yadda ya kamata tare da matakan tallafi na yau da kullun gami da rage yawan allurai, kamar yadda TRAE ta nuna wanda ya haifar da raguwar adadin G2 ILD na 2.7%. An lura da wani lamari 1 kawai na G2 ILD. Abin lura shi ne, ba a ba da rahoton mutuwar da ta shafi iza-bren ba. Ba a lura da sabbin siginar tsaro ba.
A halin yanzu, har yanzu akwai gwaje-gwaje da yawa na asibiti na sabbin fasahohin yaƙi da cutar kansa a China waɗanda ke neman marasa lafiya. Tuntuɓi kan sabbin magunguna da fasahohi, zaku iya tuntuɓar Sashen Ƙasa da Ƙasa na Asibitin Oncology na Yankin Kudu na Beijing.
Lambar Waya: 4008803716
Shaidar WeChat: 17801183037
Email：myimmnet@163.com
Lokacin Saƙo: Satumba-05-2025