NgoFebhuwaringo-2023, i-Food and Drug Administration (FDA) yasheshisa ukugunyazwa kwe-tucatinib (Tukysa, Seagen Inc.) kanye ne-trastuzumab yokwelashwa kwe-RAS wild-type HER2-positive colorectal cancer osusabalele noma ongakwazi ukususwa ngemva kwe-fluoropyrimidine- , i-oxaliplatin-, kanye ne-irinotecan-based chemotherapy.
Ilebula evulekile, ukuhlolwa kwezindawo eziningi okubizwa nge-MOUNTAINEER (NCT03043313) kuhlole ukusebenza kahle ezigulini ezingama-84. Iziguli kwakudingeka ukuthi ngaphambilini zithole ukwelashwa nge-fluoropyrimidine, oxaliplatin, irinotecan, kanye ne-anti-vascular endothelial growth factor (VEGF) monoclonal antibody ngaphezu kokuba ne-HER2-positive, RAS wild-type, unresectable, noma metastatic colorectal cancer (mAb). Abantu ababedinga i-anti-programmed cell death protein-1 mAb nabo babenomdlavuza owawungenawo amaprotheni okulungisa ukungafani (dMMR) noma ababenokungaqini kahle kwe-microsatellite (MSI-H). Iziguli ezake zithole ukwelashwa okuqondiswe kwe-anti-HER2 ngaphambilini bezingafaneleki.
Iziguli zithole i-tucatinib 300 mg ngomlomo kabili ngosuku kanye ne-trastuzumab (noma umkhiqizo we-trastuzumab ongagunyaziwe ukusetshenziswa e-United States) enikezwe ngethamo elilayishwayo elingu-8 mg/kg ngokufakwa emithanjeni ngoSuku loku-1 Lomjikelezo 1 kanye nedosi yokulondoloza engu-6 mg/ kg ngosuku loku-1 lomjikelezo wezinsuku ezingama-21 ngamunye. Iziguli zithole ukwelashwa kwaze kwaba yilapho kuqala imiphumela emibi engamukeleki.
Isilinganiso sokuphendula sisonke (ORR) kanye nobude besikhathi sokuphendula (DOR), njengoba kunqunywe isibuyekezo esizimele esiphuphuthekile, kwakuyizinyathelo ezibalulekile zokusebenza (RECIST version 1.1.). I-DOR emaphakathi yayiyizinyanga ezingu-12.4 (95% CI: 8.5, 20.5), kanti i-ORR yayingu-38% (95% CI: 28, 49).
Uhudo, ukukhathala, ukuqubuka, ukucanuzela kwenhliziyo, ukungaphatheki kahle kwesisu, izimpendulo ezihlobene nokufakwa, kanye ne-pyrexia kwakuyimiphumela emibi kakhulu (20%). Ukwenyuka kwe-creatinine, i-hyperglycemia, i-ALT, ukwehla kwe-hemoglobin, i-AST, i-bilirubin, ukwanda kwe-alkaline phosphatase, ukwehla kwama-lymphocyte, ukwehla kwe-albumin, ukuncipha kwe-leukocyte, kanye nokuncipha kwe-sodium yizinto ezingavamile zaselabhorethri (20%).
Ngokuhambisana ne-trastuzumab, umthamo wama-300 mg we-tucatinib ngomlomo kabili ngosuku uyelulekwa kuze kube yilapho isifo siqhubeka noma kunobuthi obungamukeleki.
I-Project Orbis, isinyathelo se-FDA Oncology Centre of Excellence, yasetshenziswa ukwenza lokhu kubuyekezwa. Besebenzisa ingqalasizinda ehlinzekwa yi-Project Orbis, ozakwethu bamazwe ngamazwe bangathumela futhi babuyekeze imithi ye-oncology ngesikhathi esisodwa. I-FDA kanye ne-Australian Therapeutic Goods Administration zisebenze ndawonye kulokhu kubuyekezwa (TGA). Kwenye inhlangano elawulayo, ukubuyekezwa kwesicelo kusaqhubeka.
