Hukumar Abinci da Magunguna ta amince da fruquintinib (Fruzaqla, Takeda Pharmaceuticals, Inc.) a ranar 8 ga Nuwamba, 2023, don manya marasa lafiya da ke da ciwon daji na metastatic colorectal (mCRC) waɗanda suka yi takamaiman jiyya.
An kimanta tasiri a cikin FRESCO-2 (NCT04322539) da FRESCO (NCT02314819). Gwajin FRESCO-2 (NCT04322539) ya kimanta marasa lafiya 691 tare da mCRC waɗanda suka sami ci gaba da cutar bayan fluoropyrimidine-, oxaliplatin-, irinotecan-based chemotherapy, maganin ilimin halittu na VEGF, maganin ilimin halittu na EGFR (idan RAS daji) aƙalla ɗaya na trifluridine, tipiracil, ko regorafenib. Ya kasance na kasa da kasa, cibiyar sadarwa, bazuwar, makafi biyu, binciken sarrafa wuribo. Gwajin FRESCO, wani bincike mai yawa a China, ya kimanta marasa lafiya 416 tare da metastatic maganin ciwon daji wanda ya sami ci gaba na cututtuka bayan fluoropyrimidine na baya-bayan nan-, oxaliplatin-, da kuma irinotecan na tushen chemotherapy.
A cikin gwaje-gwajen guda biyu, an sanya marasa lafiya bazuwar ko dai samun fruquintinib 5 MG da baki sau ɗaya a rana ko placebo don kwanakin 21 na farko na kowane zagayowar kwanaki 28. Sun kuma sami mafi kyawun kulawar tallafi. An bi da marasa lafiya har sai cutar ta ci gaba ko kuma rashin yarda da guba ya faru.
Sakamakon tasiri na farko a cikin gwaje-gwajen biyu shine rayuwa gaba ɗaya (OS). Matsakaicin rayuwa gaba ɗaya a cikin binciken FRESCO-2 shine watanni 7.4 (95% CI: 6.7, 8.2) ga marasa lafiya waɗanda suka karɓi fruquintinib da watanni 4.8 (95% CI: 4.0, 5.8) ga waɗanda ke cikin rukunin placebo. Matsakaicin haɗari shine 0.66 (95% CI: 0.55, 0.80) tare da p-darajar ƙasa da 0.001. A cikin binciken FRESCO, matsakaicin matsakaiciyar rayuwa shine watanni 9.3 (95% CI: 8.2-10.5) don rukunin farko na farko da watanni 6.6 (95% CI: 5.9-8.1) na biyu. Matsayin haɗari shine 0.65 (95% CI: 0.51, 0.83) kuma p-darajar ta kasance ƙasa da 0.001.
Abubuwan da suka fi dacewa (wanda aka samu ta kashi 20% ko fiye na marasa lafiya) sun haɗa da hauhawar jini, palmar-plantar erythrodysesthesia, proteinuria, dysphonia, ciwon ciki, zawo, da asthenia.
Matsakaicin adadin fruquintinib da aka ba da shawarar shine 5 MG da ake sha baki ɗaya sau ɗaya a rana, tare da ko ba tare da abinci ba, na farkon kwanaki 21 na zagaye na kwanaki 28 har sai cutar ta ci gaba ko rashin haƙuri.
Cancer
Lutetium Lu 177 dotatate an amince da shi ta USFDA don marasa lafiya na yara masu shekaru 12 da haihuwa tare da GEP-NETS
Lutetium Lu 177 dotatate, magani mai ban sha'awa, kwanan nan ya sami izini daga Hukumar Abinci da Magunguna ta Amurka (FDA) ga marasa lafiya na yara, wanda ke nuna gagarumin ci gaba a cikin ilimin cututtukan cututtukan yara. Wannan amincewar tana wakiltar alamar bege ga yara masu fama da ciwace-ciwacen ƙwayoyin cuta na neuroendocrine (NETs), nau'in ciwon daji da ba kasafai ba amma ƙalubale wanda galibi ke tabbatar da juriya ga hanyoyin warkewa na al'ada.
Alysha Mendossa
Bari 11, 2024
