Muna Februaryry 2023, the Food and Drug Administration (FDA) sped up the approval of tucatinib (Tukysa, Seagen Inc.) and trastuzumab for the treatment of RAS wild-type HER2-positive colorectal cancer that has spread or can not be removed after fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.
An open-label, multicenter experiment called MOUNTAINEER (NCT03043313) examined effectiveness in 84 patients. Patients needed to have previously received treatment with fluoropyrimidine, oxaliplatin, irinotecan, and an anti-vascular endothelial growth factor (VEGF) monoclonal antibody in addition to having HER2-positive, RAS wild-type, unresectable, or metastatic colorectal cancer (mAb). People who needed an anti-programmed cell death protein-1 mAb also had cancers that did not have mismatch repair (dMMR) proteins or had a lot of microsatellite instability (MSI-H). Patients who had previously received anti-HER2 targeted therapy were not eligible.
Varwere vakagamuchira tucatinib 300 mg nemuromo kaviri zuva nezuva pamwe chete netrastuzumab (kana chigadzirwa chetrastuzumab chisina rezinesi rekushandisa muUnited States) chakapihwa pakurodha dosi ye8 mg/kg intravenously paZuva 1 reCycle 1 uye dhigirii rekuchengetedza re6 mg/ kg paZuva 1 reimwe neimwe inotevera 21-mazuva kutenderera. Varwere vakagamuchira kurapwa kusvika pakatanga zvisingagamuchirwi mhedzisiro.
Yese mhinduro mwero (ORR) uye nguva yekupindura (DOR), sekutsanangurwa neyakapofumadzwa yakazvimirira yepakati wongororo, ndiyo yaive yakakosha matanho ekuita (RECIST vhezheni 1.1.). DOR yepakati yaiva 12.4 mwedzi (95% CI: 8.5, 20.5), uye ORR yaiva 38% (95% CI: 28, 49).
Manyoka, kupera simba, kuputika, kusvotwa, kusagadzikana mudumbu, mhinduro dzine chekuita nekupinza, uye pyrexia ndizvo zvainyanya kuitika (20%). Kuwedzera creatinine, hyperglycemia, ALT, yakaderera haemoglobin, AST, bilirubin, yakawedzera alkaline phosphatase, yakaderera lymphocytes, yakaderera albumin, yakaderera leukocytes, uye kuderera sodium ndizvo zvakanyanyozivikanwa rabhoritari abnormalities (20%).
Mukubatana ne trastuzumab, chiyero che 300 mg ye tucatinib nemuromo kaviri zuva rega rega inorayirwa kusvikira chirwere ichi chichikura kana kuti kune chepfu isingagamuchirwi.
Project Orbis, an initiative of the FDA Oncology Center of Excellence, was used to carry out this review. Using the infrastructure that Project Orbis provides, international partners can submit and review oncology medications simultaneously. The FDA and the Australian Therapeutic Goods Administration worked together on this review (TGA). At the other regulatory organisation, the application review is still proceeding.
