Nov 2023: Chikafu neDrug Administration (FDA) yakabvumidza Ivosidenib (Tibsovo, Servier Pharmaceuticals LLC) muna Mbudzi 2023 kurapwa kwevarwere vakura vane kudzokazve kana refractory myelodysplastic syndromes (MDS) vane inotapukira isocitrate dehydrogenase-1 (IDH1) shanduko zvichienderana ne FDA-yakatenderwa bvunzo.
Iyo FDA yakabvumidzawo iyo Abbott RealTime IDH1 Assay sechishandiso chekuongorora chekusarudza varwere kuti vagamuchire ivosidenib.
Mvumo yakabva pa AG120-C-001 (NCT02074839), imwe-ruoko, yakazaruka-label, multicenter kuedza nevarwere vakuru vane 18 vakanga vadzokera shure kana kuti refractory MDS uye IDH1 mutation. IDH1 shanduko dzakaonekwa kuburikidza nekushandiswa kwenzvimbo kana yepakati kuongororwa bvunzo muropa reperipheral kana mwongo wepfupa, uye yakazosimbiswa kuburikidza nekudzokororwa kuongororwa uchishandisa iyo Abbott RealTime IDH1 Assay.
Inosidenib yemuromo yaishandiswa pachiyero chekutanga che 500 mg pazuva nenzira inopfuurira kwemazuva 28, kana kusvika hematopoietic stem cell transplantation, kufambira mberi kwechirwere, kana chepfu isingagamuchirwi yakaitika. Nguva yenguva yekurapa yaiva 9.3 mwedzi. Mushure mekugamuchira ivosidenib, stem cell transplant yakaitwa pane mumwe murwere.
Muyero wekubva pakuda kuwedzerwa ropa kusvika pakusavada, chiyero chekuregererwa kwakakwana (CR) kana chikamu chekuregererwa (PR) (2006 International Working Group mhinduro yeMDS), uye hurefu hweCR + PR hwakashandiswa kutonga zvakanaka. kurapwa kwakashanda. Imwe neimwe yakaonekwa mhinduro yakaita CR. 389.9% yaiva CR rate (95% CI: 17.3, 64.3%). Nguva yepakati-ku-CR yaive mwedzi 1.9, ine huwandu hwe1.0 kusvika kumwedzi 5.6. Nekudaro, iyo yepakati nguva yeCR haigone kufungidzirwa, kubva pa1.9 kusvika 80.8+ mwedzi. Kubva pavarwere vapfumbamwe vakatanga kuvimba neropa dzvuku (RBC) uye kuwedzerwa kweplatelet, vatanhatu (67%) vakawana rusununguko kubva kuRBC uye kuisirwa kweplatelet mukati memazuva makumi mashanu nematanhatu mushure mekutanga. Vanomwe kubva kune vapfumbamwe varwere vakanga vasina kuwedzerwa ropa pakutanga, kusanganisira platelet uye kuwedzerwa kweRBC, vakaramba vasina kuwedzerwa ropa chero ipi zvayo yemazuva 56 mushure mekutanga (56 muzana).
Kuenzaniswa nemaitiro akashata anowanzoonekwa neivosidenib monotherapy ye AML, uku ndiko kwaiwanzoita kwakashata. Mukuwedzera kune gastrointestinal (kuvimbiswa, kusvotwa, arthralgia, lethargy, chikosoro, uye myalgia), zviratidzo izvi zvinosanganisira kuputika uye arthralgia. Iyo QTc inogona zvakare kurebeswa neTibsovo.
Yambiro yeBhokisi inosanganisirwa muruzivo rwekuyambira varwere nenyanzvi dzehutano nezve njodzi inogona kuuraya yekusiyanisa syndrome.
Wona ruzivo rwakazara rwekutemerwa kweTibsovo.
