Noofambar 2023: Maamulka Cuntada iyo Dawooyinka (FDA) ayaa ansixiyay Ivosidenib (Tibsovo, Server Pharmaceuticals LLC) bishii Noofambar 2023 daaweynta bukaannada qaangaarka ah ee leh dib-u-soo-kabashada ama cilladaha myelodysplastic syndromes (MDS) kuwaas oo leh cillad isocitrate dehydrogenase-1 (IDH1) isbeddelka Tijaabada FDA-ansixisay.
FDA waxay kaloo ansixisay Abbott RealTime IDH1 Assay inay tahay qalab lagu ogaanayo saaxiibka si ay u doortaan bukaanada si ay u helaan ivosidenib.
Oggolaanshaha waxa lagu saleeyay AG120-C-001 (NCT02074839), cudud keliya, calaamad furan, tijaabo xarun badan leh oo leh 18 bukaan oo qaangaar ah oo soo noqnoqday ama dib u celinaya MDS iyo isbeddelka IDH1. Isbeddellada IDH1 waxaa lagu aqoonsaday iyadoo la adeegsanayo baaritaannada ogaanshaha gudaha ama dhexe ee dhiigga ku hareeraysan ama dhuuxa lafta, ka dibna lagu ansixiyay falanqayn dib-u-eegis ah iyadoo la adeegsanayo Abbott RealTime IDH1 Assay.
Inosidenib afka waxaa lagu maamulay qiyaasta bilawga ah ee 500 mg maalintii si joogto ah muddo 28 maalmood ah, ama ilaa tallaalka unugyada tarma ee hematopoietic, horumarka cudurka, ama sunta aan la aqbali karin ayaa dhacday. Celceliska muddada daawaynta waxay ahayd 9.3 bilood. Ka dib markii la helay ivosidenib, tallaalka unugyada asliga ah ayaa lagu sameeyay hal bukaan.
Qiyaasta laga bilaabo u baahan dhiig ku shubista ilaa aan loo baahnayn, heerka cafiska dhamaystiran (CR) ama qayb cafiska (PR) (2006 jawaabta kooxda caalamiga ah ee MDS), iyo dhererka CR + PR ayaa loo adeegsaday si loo qiimeeyo sida ugu wanaagsan daawaynta ayaa shaqaysay. Jawaab kasta oo la arkay waxay ka koobnayd CR. 389.9% wuxuu ahaa heerka CR (95% CI: 17.3, 64.3%). Waqtiga dhexdhexaadka ah ee-CR wuxuu ahaa 1.9 bilood, oo u dhexeeya 1.0 ilaa 5.6 bilood. Si kastaba ha ahaatee, muddada dhexdhexaadka ah ee CR lama qiyaasi karo, oo ka bilaabanta 1.9 ilaa 80.8+ bilood. Sagaalkii bukaan ee markii hore ku tiirsanaa unugga dhiigga cas (RBC) iyo dhiig-shubidda platelet, lix (67%) waxay ka madaxbannaanaadeen RBC iyo dhiig-shubidda platelet muddo 56 maalmood ah gudahood ka dib markii la saleeyey. Sagaalkii bukaanba todoba ka mid ah kuwaas oo aan dhiig ku shubin markii hore, oo ay ku jiraan dhiig-shubitaannada platelet iyo RBC, ayaa ku hadhay dhiig-shubid-la'aan muddo 56-maalmood ah ka dib xilliga aasaasiga ah (78 boqolkiiba).
Marka la barbar dhigo falcelinta xun ee soo noqnoqda ee lagu arkay ivosidenib monotherapy ee AML, kuwani waxay ahaayeen falcelinta xun xun ee soo noqnoqda. Marka laga reebo caloosha (calool- istaag, lallabbo, arthralgia, caajisnimo, qufac, iyo myalgia), calaamadahan sidoo kale waxaa ka mid ah finan iyo arthralgia. QTc waxa kale oo laga yaabaa in ay kordhiso Tibsovo.
Digniinta Sanduuqa ah ayaa lagu soo daray macluumaadka qorida si loogu digo bukaannada iyo xirfadlayaasha daryeelka caafimaadka khatarta kala-duwanaanta cilladda ee khatarta ah.
U fiirso macluumaadka buuxa ee Tibsovo.
