Chikafu neDrug Administration yakabvumidza nirogacestat (OGSIVEO, SpringWorks Therapeutics, Inc.) muna Mbudzi 27, 2023, yevarwere vakuru vane mabundu ari kufambira mberi anoda systemic kurapwa. Iyi ndiyo yekutanga yakatenderwa kurapa kwe desmoid tumors.
Chidzidzo chinonzi DeFi (NCT03785964) chakatarisa kuti chakashanda sei. Yakanga iri yepasi rose, yakawanda, yakasarudzika (1: 1), mapofu maviri-mapofu, e placebo-inodzorwa kuyedza nevarwere ve142 vaive nemamota edemoid aive achiwedzera kuipa uye asingakwanisi kurapwa nekuvhiyiwa. Varwere vaikwanisa kana bundu re desmoid rakanga rafambira mberi mukati memwedzi ye12 mushure mekuongororwa. Vatori vechikamu vakagoverwa kuti vatore 150 mg ye nirogacestat kana placebo nemuromo kaviri pazuva kusvikira kurwara kufambira mberi kana kusagadzikana kunotyisa.
Progression-free survival (PFS) yakaverengerwa neRECIST v1.1 neyakapofumadzwa yakazvimiririra yepakati ongororo kana kufambira mberi kwekiriniki kwakaongororwa nemuongorori uye kuongororwa kwakazvimiririra yaive nzira huru yekuyera kuti kurapwa kwakashanda sei. Kupona kwepakati-pasina kurarama (PFS) hakuna kutsanangurwa muboka renirogacestat (95% CI: isina kutsanangurwa) uye yaive mwedzi 15.1 (95% CI: 8.4, isina kutsanangurwa) muboka re placebo. The hazard ratio (HR) yaiva 0.29 (95% CI: 0.15, 0.55) ine p-value isingasviki 0.001. Ongororo yekutanga yekufambira mberi-isina kupona (PFS) uchishandisa chete radiographic kufambira mberi kwakaratidza huwandu hwengozi ye0.31 (95% CI: 0.16, 0.62).
Iyo chinangwa chekuita mwero (ORR) yaive imwe chiyero chekubudirira. The Objective Response Rate (ORR) yaiva 41% (95% CI: 29.8, 53.8) yevatori vechikamu muboka re nirogacestat uye 8% (95% CI: 3.1, 17.3) kune avo vari muboka re placebo (p-value = <0.001 ) Kuvandudzwa kwemurwere-kushumwa kwakaipisisa kubva pakutanga kwekudzidza, iyo yaifarira boka re nirogacestat, yakawedzera kusimbisa migumisiro yekushanda.
Migumisiro yakaipisisa yaisanganisira manyoka, huturu hwe ovarian, rash, kusvotwa, kuneta, stomatitis, kutemwa nemusoro, kusagadzikana kwemudumbu, kukosora, alopecia, hutachiona hwepamusoro hwekufema, uye dyspnea.
Iyo yakataurwa nirogacestat dosage ndeye 150 mg inotorwa nemuromo kaviri pazuva, ine kana pasina chikafu, kusvika hurwere hwakura kana pane huturu husingagamuchirwe. Imwe yega yega ye150 mg inoumbwa nemapiritsi matatu 50 mg.
kenza
Lutetium Lu 177 dotatate inotenderwa neUSFDA kune vana vane makore gumi nemaviri zvichikwira neGEP-NETS.
Lutetium Lu 177 dotatate, kurapwa kwepasi, ichangobva kugamuchira mvumo kubva kuUS Food and Drug Administration (FDA) yevarwere vevana, zvichiratidza chiitiko chakakosha muvana oncology. Mvumo iyi inomiririra chiedza chetariro kuvana vari kurwisana neuroendocrine tumors (NETs), isingawanzowanikwi asi inonetsa yegomarara iro rinowanzoratidza kuti rinoshingirira pakurapa kwakajairika.
Alysha Mendossa
Dai 11, 2024
