A cikin FabrairuA cikin 2023, Hukumar Abinci da Magunguna (FDA) ta haɓaka amincewar tucatinib (Tukysa, Seagen Inc.) da trastuzumab don maganin RAS daji-nau'in HER2-tabbataccen ciwon daji wanda ya yadu ko ba za a iya cirewa ba bayan fluoropyrimidine- , oxaliplatin-, da irinotecan na tushen chemotherapy.
Wani buɗaɗɗen lakabin, gwaji na cibiyar sadarwa mai suna MOUNTAINEER (NCT03043313) yayi nazarin tasiri a cikin marasa lafiya 84. Marasa lafiya da ake buƙatar a baya sun karɓi magani tare da fluoropyrimidine, oxaliplatin, irinotecan, da kuma ƙwayar cuta ta ƙwayar cuta ta endothelial (VEGF) antibody antibody ban da samun HER2-tabbatacce, RAS daji-nau'i, unresectable, ko metastatic colorectal ciwon daji (mAb). Mutanen da ke buƙatar furotin mutuwar cell-1 mAb kuma suna da ciwon daji waɗanda ba su da sunadaran gyaran gyare-gyare (dMMR) ko suna da rashin zaman lafiya na microsatellite (MSI-H). Marasa lafiya waɗanda a baya sun karɓi maganin rigakafin HER2 da aka yi niyya ba su cancanci ba.
Marasa lafiya sun karɓi tucatinib 300 MG da baki sau biyu a rana tare da trastuzumab (ko samfurin trastuzumab ba lasisi don amfani da shi a Amurka) wanda aka ba shi a cikin nauyin ɗaukar nauyin 8 mg / kg a cikin jini a ranar 1 na Cycle 1 da adadin kulawa na 6 mg / kg a ranar 1 na kowane zagayowar kwanaki 21 masu zuwa. Marasa lafiya sun sami magani har zuwa farkon illolin da ba za a yarda da su ba.
Yawan amsa gabaɗaya (ORR) da tsawon lokacin amsawa (DOR), kamar yadda aka ƙaddara ta hanyar bita ta tsakiya mai zaman kanta mai zaman kanta, sune mahimman matakan ingantaccen aiki (Sigar RECIST 1.1.). Matsakaicin DOR shine watanni 12.4 (95% CI: 8.5, 20.5), kuma ORR shine 38% (95% CI: 28, 49).
Zawo, gajiya, kurji, tashin zuciya, rashin jin daɗi na ciki, martani masu alaƙa da jiko, da pyrexia sune mafi yawan sakamako masu illa (20%). Ƙara creatinine, hyperglycemia, ALT, raguwar haemoglobin, AST, bilirubin, ƙara yawan alkaline phosphatase, rage lymphocytes, rage albumin, rage leukocytes, da rage sodium sune mafi yawan rashin lafiyar dakin gwaje-gwaje (20%).
Tare da haɗin gwiwa tare da trastuzumab, ana ba da shawarar kashi 300 na tucatinib a baki sau biyu a rana har sai cutar ta ci gaba ko kuma akwai guba maras yarda.
Project Orbis, wani yunƙuri na Cibiyar Inganta Oncology na FDA, an yi amfani da shi don aiwatar da wannan bita. Yin amfani da kayan aikin da Project Orbis ke bayarwa, abokan tarayya na duniya zasu iya ƙaddamarwa da kuma duba magungunan oncology lokaci guda. FDA da Hukumar Kula da Kaya ta Ostiraliya sun yi aiki tare akan wannan bita (TGA). A wata ƙungiyar ƙa'ida, binciken aikace-aikacen yana ci gaba da gudana.
