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-mapofu, placebo-inodzorwa kudzidza. Muyedzo weFRESCO, chidzidzo chakawanda muChina, chakaongorora varwere mazana mana negumi 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 muboka refruquintinib kwaive mwedzi 7.4 (95% CI: 6.7, 8.2) zvichienzaniswa nemwedzi 4.8 (95% CI: 4.0, 5.8) muboka re placebo. Huwandu hwengozi hwaive 0.66 (95% CI: 0.55, 0.80) ine p-value isingasviki 0.001. Kupona kwepakati pese (OS) muongororo yeFRESCO yaive mwedzi 9.3 (95% CI: 8.2, 10.5) uye mwedzi 6.6 (95% CI: 5.9, 8.1) mumapoka akasiyana ekurapa. The hazard ratio (HR) yaiva 0.65 (95% CI: 0.51, 0.83) ine nhamba inokosha p-value 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.
Wona ruzivo rwakazara rwekurayira fruquintinib.
