Dina Pébruariry 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.
Pasén nampi tucatinib 300 mg sacara lisan dua kali sadinten sareng trastuzumab (atanapi produk trastuzumab henteu dilisensikeun pikeun dianggo di Amérika Serikat) dipasihkeun dina dosis loading 8 mg / kg sacara intravena dina Poé 1 Siklus 1 sareng dosis pangropéa 6 mg / kg dina Poé 1 unggal siklus 21 poé saterusna. Pasén narima perlakuan nepi ka awal efek samping unacceptable.
Gemblengna laju respon (ORR) jeung lilana respon (DOR), sakumaha ditangtukeun ku review sentral bebas buta, éta ukuran efficacy konci (versi RECIST 1.1.). DOR median nyaéta 12.4 bulan (95% CI: 8.5, 20.5), sareng ORR nyaéta 38% (95% CI: 28, 49).
Diare, létoy, baruntus, seueul, teu ngarareunah beuteung, réspon nu patali infusion, sarta pyrexia éta efek samping paling sering (20%). Paningkatan kréatinin, hiperglikemia, ALT, turunna hémoglobin, AST, bilirubin, ningkat fosfatase alkali, panurunan limfosit, turunna albumin, turunna leukosit, sareng turunna natrium mangrupikeun abnormalitas laboratorium anu paling umum (20%).
Dina kombinasi sareng trastuzumab, dosis 300 mg tucatinib sacara lisan dua kali sadinten disarankeun dugi ka panyakit maju atanapi aya karacunan anu teu tiasa ditampi.
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.
