I-Servier namhlanje ibhengeze ukuba i-US Food and Drug Administration (i-FDA) yamkele i-supplementary New Drug Application (sNDA) yenkampani ye-TIBSOVO® (iipilisi ze-ivosidenib) njengonyango olunokubakho kwizigulane ezine-IDH1-mutated acute myeloid leukemia (AML) engazange iphathwe ngaphambili. I-sNDA inikwe ukuPhononongwa okuPhambili, okukhawulezisa ukuphononongwa kunye nokunciphisa injongo yexesha lokuphonononga ukusuka kwiinyanga ze-10 ukuya kwiinyanga ze-6. UPhononongo oluBalulekileyo lunikezelwa kumachiza anokubonelela ngenkqubela phambili enkulu kunyango okanye anokubonelela ngonyango apho kungekho nyango lwaneleyo lukhoyo.
"Kwizithende zemvume yethu yamva nje ye-FDA ye-TIBSOVO kwi-cholangiocarcinoma, siyavuya ngeli nyathelo elibalulekileyo eliya phambili ekuqwalaseleni i-arhente yokwandisa isalathiso sangoku ukubandakanya unyango lwezigulane ezine-IDH1-mutated acute myeloid leukemia ngaphambili," watsho uDavid. K. Lee, iGosa eliyiNtloko yesiGqeba, i-Servier Pharmaceuticals. “Sichulumancile ngamandla akhuthazayo ale nkqubo njengoko siqhubeka nokukhulisa ubunkokeli bethu kwi-oncology kwaye sihambisa amayeza atshintsha ubomi kwizigulana eziphila nomhlaza ekunzima ukuwunyanga.”
Ukwamkelwa kwe-sNDA kuxhaswa ziziphumo ezivela kwisifundo se-AGILE, i-global, iSigaba se-3 solingo kwizigulane ezine-IDH1-mutated AML ngaphambili, eziye zanikezelwa kwi-2021 American Society of Hematology Annual Meeting and Exposition. Idatha ibonise ukuba unyango kunye ne-TIBSOVO ngokudibanisa ne-azacitidine iphucule kakhulu ukusinda kwesiganeko (EFS) (umlinganiselo wengozi [HR] = 0.33, 95% CI 0.16, 0.69, 1-sided P = 0.0011 1,2). Ukongezelela, ukudibanisa kwe-TIBSOVO kunye ne-azacitidine ibonise ukuphucuka okuphawulekayo kwi-statistical survival (OS) (HR = 0.44 [95% CI 0.27, 0.73]; i-1-sided P = 0.0005), kunye ne-OS ephakathi kweenyanga ze-24.0.
"I-TIBSOVO yonyango lokuqala olujolise kwi-metabolism yomhlaza ukubonisa ukuphuculwa kokusinda kwesiganeko kunye nokusinda ngokubanzi ngokudibanisa ne-azacitidine kwizigulane ezine-IDH1-mutated AML ngaphambili," watsho uSusan Pandya, MD, uSekela Mongameli woPhuhliso lweKlinikhi kunye neNtloko yeCancer Metabolism Global. I-Oncology yoPhuhliso kunye ne-Immuno-Oncology, i-Servier Pharmaceuticals. "Ngolu kwamkelwa kwe-FDA kuPhononongo oluPhambili, sikufutshane ekunikeni olu khetho lubalulekileyo lonyango kwizigulana zase-US kwaye sijonge phambili ekusebenzisaneni neearhente ezilawulayo kwihlabathi liphela."
I-TIBSOVO[*] okwangoku ivunyiwe e-US njengonyango lwe-monotherapy kunyango lwabantu abadala abane-IDH1-mutant ebuyiselweyo okanye i-refractory acute myeloid leukemia (AML), kunye nakubantu abadala abane-IDH1-mutant AML esandula kufunyaniswa ukuba ≥75 yeminyaka ubudala okanye abane-AML eguquguqukayo. i-comorbidities evimbela ukusetyenziswa kwe-chemotherapy induction intensive. Kutshanje, i-TIBSOVO ivunyiwe njengonyango lokuqala nolujoliswe kuphela kwizigulane ezine-IDH1 eguqulweyo ye-cholangiocarcinoma eguqulweyo.
Kwiinzame zokuzisa iindlela ezintsha zonyango kwizigulane eziphila nomhlaza ekunzima ukuwunyanga, u-Servier wenze i-oncology ibe yinto ephambili kwihlabathi, kwaye yabela ngaphezu kwe-50% yohlahlo lwabiwo-mali lophando kunye nophuhliso kuphando lomhlaza. Ngaphezulu kwe-asethi ye-oncology engama-21 kumanqanaba ahlukeneyo ophuhliso lwezonyango, kunye neeprojekthi zophando ezingama-20 eziqhubekayo, u-Servier uzibophelele ekufumaneni izisombululo ezijongana neemfuno zesigulane kulo lonke uhlobo lwesifo nakwiindidi zethumba.
