I-Fruquintinib igunyazwe yi-USFDA kumdlavuza we-metastatic colorectal refractory

I-Food and Drug Administration igunyaze i-fruquintinib (i-Fruzaqla, i-Takeda Pharmaceuticals, Inc.) ngoNovemba 8, 2023, ezigulini ezikhulile ezinomdlavuza we-metastatic colorectal (mCRC) ezithole ukwelashwa okukhethekile kwangaphambili.

Ukusebenza kuhlolwe ku-FRESCO-2 (NCT04322539) kanye ne-FRESCO (NCT02314819). Isivivinyo se-FRESCO-2 (NCT04322539) sihlole iziguli ezingama-691 ezine-mCRC ezithole ukuqhubeka kwesifo ngemuva kwe-fluoropyrimidine-, oxaliplatin-, i-irinotecan-based chemotherapy, i-anti-VEGF biological therapy, i-anti-EGFR biological therapy (uma uhlobo lwasendle lwe-RAS) lwangaphambilini. okungenani eyodwa ye-trifluridine, i-tipiracil, noma i-regorafenib. Kwakuwucwaningo lwamazwe ngamazwe, olugxile ezindaweni eziningi, olungahleliwe, olungaboni kabili, olulawulwa yi-placebo. Isivivinyo se-FRESCO, isifundo se-multicenter e-China, sihlole iziguli ezingama-416 ezine-metastatic umdlavuza colorectal owathola ukuqhubekela phambili kwesifo kulandela i-fluoropyrimidine-, i-oxaliplatin-, ne-irinotecan-based chemotherapy yangaphambilini.

Kuzo zombili izinhlolo, iziguli zabelwa ngokungahleliwe ukuthi zithole i-fruquintinib 5 mg ngomlomo kanye ngosuku noma i-placebo ezinsukwini zokuqala ezingama-21 zomjikelezo ngamunye wezinsuku ezingama-28. Baphinde bathola ukunakekelwa okungcono kakhulu okusekelayo. Iziguli zalashwa kuze kube yilapho kuvela isifo noma ubuthi obungamukeleki.

Umphumela oyinhloko wokusebenza ngempumelelo kuzo zombili izivivinyo kwaba ukusinda okuphelele (OS). Ukusinda okuphelele okumaphakathi ocwaningweni lwe-FRESCO-2 kwakuyizinyanga ezingu-7.4 (95% CI: 6.7, 8.2) ezigulini ezithole i-fruquintinib nezinyanga ezingu-4.8 (95% CI: 4.0, 5.8) kulabo abaseqenjini le-placebo. Isilinganiso sengozi sasingu-0.66 (95% CI: 0.55, 0.80) ngenani lika-p elingaphansi kuka-0.001. Ocwaningweni lwe-FRESCO, ukusinda okuphelele okuphakathi kwakuyizinyanga ezingu-9.3 (95% CI: 8.2-10.5) eqenjini lokuqala lokwelapha kanye nezinyanga ezingu-6.6 (95% CI: 5.9-8.1) okwesibili. Isilinganiso sengozi sasingu-0.65 (95% CI: 0.51, 0.83) futhi inani le-p lalingaphansi kuka-0.001.

Imiphumela emibi evamile (etholwe iziguli ezingamaphesenti angu-20 noma ngaphezulu) yayihlanganisa umfutho wegazi ophakeme, i-palmar-plantar erythrodysesthesia, i-proteinuria, i-dysphonia, ubuhlungu besisu, isifo sohudo, kanye ne-asthenia.

Umthamo ophakanyisiwe we-fruquintinib ngu-5 mg othathwa ngomlomo kanye ngosuku, ngokudla noma ngaphandle kokudla, ezinsukwini zokuqala ezingama-21 zomjikelezo wezinsuku ezingama-28 kuze kube yilapho isifo siqhubeka noma ubuthi obungabekezeleleki.