Chikafu neDrug Administration yakabvumidza fruquintinib (Fruzaqla, Takeda Pharmaceuticals, Inc.) munaNovember 8, 2023, yevarwere vakuru vane metastatic colorectal cancer (mCRC) vakamborapwa kare.
Kubudirira kwakaongororwa muFRESCO-2 (NCT04322539) uye FRESCO (NCT02314819). Muyedzo weFRESCO-2 (NCT04322539) wakaongorora varwere mazana matanhatu nemakumi mapfumbamwe nemumwe vane mCRC vakaona kufambira mberi kwechirwere mushure mekare fluoropyrimidine-, oxaliplatin-, irinotecan-based chemotherapy, anti-VEGF biological therapy, anti-EGFR biological therapy (kana RAS mhuka yemusango), uye pa imwe ye trifluridine, tipiracil, kana regorafenib. Yakanga iri yepasi rose, yakawanda, yakasarudzika, yakapetwa kaviri-mapofu, placebo-inodzorwa kudzidza. Muyedzo weFRESCO, chidzidzo chakawanda muChina, chakaongorora varwere mazana mana nemakumi mana nevatanhatu vane metastatic kenza yakajeka avo vakawana kufambira mberi kwechirwere zvichitevera yapfuura fluoropyrimidine-, oxaliplatin-, uye irinotecan-based chemotherapy.
Mune miedzo miviri, varwere vakagoverwa kuti vawane fruquintinib 5 mg nemuromo kamwe chete pazuva kana placebo kwemazuva 21 ekutanga kwemazuva makumi maviri nemasere. Vakawanawo rubatsiro rwakanakisisa runobvira. Varwere vairapwa kusvikira kufambira mberi kwechirwere kana kuti huturu husingagamuchirwi hwaitika.
Mhedzisiro yekutanga yekubudirira mune ese ari maviri miedzo yaive kupona kwese (OS). Kupona kwepakati pese muFRESCO-2 kudzidza yaive mwedzi 7.4 (95% CI: 6.7, 8.2) kune varwere vakagamuchira fruquintinib uye 4.8 mwedzi (95% CI: 4.0, 5.8) kune avo vari muboka re placebo. Huwandu hwengozi yaive 0.66 (95% CI: 0.55, 0.80) ine p-value isingasviki 0.001. Muchidzidzo cheFRESCO, hupenyu hwepakati hwepakati hwakanga huri 9.3 mwedzi (95% CI: 8.2-10.5) yeboka rekutanga rekurapa uye mwedzi 6.6 (95% CI: 5.9-8.1) yechipiri. Huwandu hwengozi hwaive 0.65 (95% CI: 0.51, 0.83) uye p-value yaive isingasviki 0.001.
Migumisiro yakapararira (yakaitika ne20% kana kupfuura yevarwere) yaisanganisira hypertension, palmar-plantar erythrodysesthesia, proteinuria, dysphonia, kurwadziwa kwepamuviri, manyoka, uye asthenia.
Iyo yakakurudzirwa fruquintinib dosage ndeye 5 mg inotorwa nemuromo kamwe chete pazuva, ine kana isina chikafu, kwekutanga 21 mazuva e28-zuva kutenderera kusvika kufambira mberi kwechirwere kana huturu husingaregi.
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
