August 2021: Iyo FDA yakapa mvumo yekukurumidza kune sotorasib (LumakrasTM, Amgen, Inc.), RAS GTPase mhuri inhibitor, yevarwere vakuru vane KRAS G12C yakachinja munharaunda yepamusoro kana metastatic isiri diki cell lung cancer (NSCLC) avo vakawana kamwechete kekutanga systemic therapy, sekutemerwa neFDA-yakatenderwa bvunzo.
Semufambidzani wekuongorora kweLumakras, iyo FDA yakabvumidza iyo QIAGEN therascreen® KRAS RGQ PCR kit (tissue) uye Guardant360® CDx (plasma). Iyo bundu matishu inofanirwa kuongororwa kana pasina shanduko inowanikwa mumuenzaniso weplasma.
Mvumo yacho yakavakirwa paCodeBreaK 100, multicenter, single-arm, open label clinical study (NCT03600883) iyo yaisanganisira varwere vane KRAS G12C mutations vakange vafambira munharaunda kana metastatic NSCLC. Kushanda kwemushonga kwakaedzwa muvarwere ve124 vane chirwere chaive chafambira mberi kana mushure menguva imwechete yapfuura systemic therapy. Sotorasib 960 mg nemuromo kamwe pazuva yaipiwa kuvarwere kusvika kufambira mberi kwechirwere kana kusashivirira chepfu.
Mhedzisiro yekutanga yekubudirira yaive yechinangwa chekupindura mwero (ORR) zvinoenderana neRECIST 1.1, sekutsanangurwa kwakapofumadzwa kwakazvimirira kwepakati wongororo, uye kureba kwekupindura. Nenguva yekupindura yepakati yemwedzi gumi (renji 10+, 1.3), ORR yaive 11.1 muzana (36 muzana CI: 95 muzana, 28 muzana).
Diarrhea, marwadzo emusculoskeletal, kusvotwa, kupera simba, hepatotoxicity, uye kukosora ndizvo zvaive zvakanyanya kuitika (20%). Yakaderera lymphocytes, yakaderera haemoglobin, yakawedzera aspartate aminotransferase, yakawedzera alanine aminotransferase, yakaderera calcium, yakawedzera alkaline phosphatase, yakawedzera weti protein, uye kuderera kwesodium ndizvo zvakanyanya kupararira murabhoritari abnormalities (25 muzana).
Sotorasib inotorwa kamwe chete pazuva, ine kana isina chikafu, pachiyero che960 mg.
Iyo 960 mg dose yakagamuchirwa zvichienderana neuchapupu hwekiriniki huripo pamwe ne pharmacokinetic uye pharmacodynamic simulations yakatsigira huwandu. Iyo FDA irikuda kuyedza kushambadza sechikamu chekuongororwa kwemvumo iyi yekukurumidzira kuona kana dosi rakaderera riine kurapa kwakafanana.
Referensi: https://www.fda.gov/
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