Ndira 2023: Adagrasib (Krazati, Mirati Therapeutics, Inc.), RAS GTPase mhuri inhibitor, yakapihwa yakakurumidza kubvumidzwa neFood and Drug Administration (FDA) yevarwere vakuru vane KRAS G12C-yakashandurwa munharaunda yepamusoro kana metastatic isiri diki cell lung cancer (NSCLC), sezvakaonekwa neFDA-yakatenderwa bvunzo. , avo vakagamuchira kanenge kamwe chete kwekutanga systemic therapy.
Sekuwedzera kumwe kuongororwa kweKrazati, iyo FDA yakawedzera kubvumidza iyo QIAGEN therascreen KRAS RGQ PCR kit (tishu) uye Agilent Resolution ctDx FIRST Assay (plasma). Iyo bundu matishu inofanirwa kuongororwa kana pakange pasina chiratidzo chekuchinja mumuenzaniso weplasma.
The KRYSTAL-1 kliniki yekuedzwa (NCT03785249), which involved patients with locally advanced or metastatic NSCLC with KRAS G12C mutations, served as the foundation for the approval. Efficacy was assessed in 112 individuals whose illness had advanced during or after receiving immune checkpoint inhibitors and platinum-based chemotherapy, either concurrently or sequentially. Patients got adagrasib 600 mg twice daily until their condition progressed or the side effects became intolerable.
Iyo yekutanga efficacy mhedzisiro zviyero yaive nguva yekupindura uye yakasimbiswa chinangwa chekupindura mwero (ORR) zvinoenderana neRECIST 1.1, sekuongororwa neakapofumadzwa akazvimirira central wongororo (DOR). DOR yepakati yaiva mwedzi 8.5 (95% CI: 6.2, 13.8), uye ORR yaiva 43% (95% CI: 34%, 53%).
Manyoka, kusvotwa, kuneta, kurutsa, kurwadziwa kwemusculoskeletal, hepatotoxicity, renal impairment, dyspnea, edoema, kuderera kwechido, kukosora, mabayo, kuvhiringidzika, kuvharwa, kurwadziwa kwepamuviri, uye QTc interval prolongation ndiyo yainyanya kuitika (20%). Yakaderedzwa lymphocytes, yakawedzera aspartate aminotransferase, yakawedzera sodium, yakaderera sodium, yakaderera haemoglobin, yakawedzera creatinine, yakaderera albumin, yakawedzera alanine aminotransferase, yakawedzera lipase, yakaderera maplatelet, yakaderera magnesium, uye yakaderera potassium ndiyo yainyanya kuwanda yerabhoritari abnormalities (25%).
Adagrasib mapiritsi anofanirwa kutorwa nemuromo kaviri pazuva pachiyero che 600 mg kusvikira mamiriro acho achienderera mberi kana kuti pane huturu husingagoneki.
