Bishii FebraayoSannadkii 2023, Maamulka Cuntada iyo Dawooyinka (FDA) ayaa dardar galiyay oggolaanshaha tucatinib (Tukisa, Seagen Inc.) iyo trastuzumab ee daaweynta RAS-nooca duurjoogta ah ee HER2 kansarka mindhicirka oo faafay ama aan laga saari karin ka dib fluoropyrimidine- , oxaliplatin-, iyo kiimoterabi ku salaysan irinotecan.
Sumad furan, tijaabo xarumo badan leh oo la yiraahdo MOUNTAINEER (NCT03043313) ayaa baadhay waxtarka bukaanada 84. Bukaannada loo baahan yahay in ay hore u heleen daawaynta fluoropyrimidine, oxaliplatin, irinotecan, iyo anti-vascular endothelial factor factor (VEGF) monoclonal antibody marka lagu daro HER2-positive, RAS-nooca duurjoogta ah, aan la daweyn karin, ama kansarka mindhicirka ee metastatic (mAb). Dadka u baahday borotiinka dhimashada unugyada borotiinka-1mAb sidoo kale waxay lahaayeen kansar kuwaas oo aan lahayn borotiinada dayactirka (dMMR) ama waxay lahaayeen xasillooni darro badan oo microsatellite ah (MSI-H). Bukaannada horay u qaatay daawaynta la beegsanayo ee HER2 uma qalmin.
Bukaan-socodka ayaa qaatay tucatinib 300 mg afka laba jeer maalin kasta oo ay la socoto trastuzumab (ama badeecada trastuzumab ee aan shatiga u haysanin isticmaalka Maraykanka) oo la siiyay qiyaasta 8 mg/kg xididada xididka maalinta 1 ee wareegga 1 iyo qiyaasta dayactirka ee 6 mg / kg ee maalinta 1 ee wareeg kasta oo xiga 21-maalin. Bukaanku waxay heleen daawaynta ilaa bilawga saameynaha aan la aqbali karin.
Heerka jawaabta guud (ORR) iyo muddada jawaabta (DOR), sida lagu go'aamiyay dib-u-eegis dhexe oo madax-bannaan oo indho la'aan ah, ayaa ahaa tallaabooyinka waxtarka leh ee muhiimka ah (nooca RECIST 1.1.). Dhexdhexaadka DOR wuxuu ahaa 12.4 bilood (95% CI: 8.5, 20.5), ORR wuxuu ahaa 38% (95% CI: 28, 49).
Shuban, caajisnimo, finan, lallabbo, calool xanuun, jawaabaha faleebada la xidhiidha, iyo pyrexia ayaa ah dhibaatooyinka soo noqnoqda (20%). Kordhinta creatinine, hyperglycemia, ALT, hoos u dhaca haemoglobin, AST, bilirubin, korodhka fosfatase alkaline, hoos u dhaca lymphocytes, hoos u dhaca albumin, hoos u dhaca leukocytes, iyo hoos u soodiyam ah cilladaha shaybaarka ugu baahsan (20%).
Iyadoo lala kaashanayo trastuzumab, qiyaasta 300 mg ee tucatinib afka laba jeer maalintii ayaa lagula talinayaa ilaa uu cudurku ka sii socdo ama ay jirto sun aan la aqbali karin.
Project Orbis, hindise ka mid ah Xarunta Sare ee Oncology ee FDA, ayaa loo isticmaalay in lagu fuliyo dib u eegistan. Isticmaalka kaabayaasha ay bixiso Project Orbis, la-hawlgalayaasha caalamiga ah waxay soo gudbin karaan oo ay dib u eegis ku samayn karaan daawooyinka kansarka isku mar. FDA iyo Australian Therapeutic Products ayaa ka wada shaqeeyay dib u eegistan (TGA). Hay'adda kale ee sharciyaynta, dib u eegista codsigu wali way socotaa.
