UServier namuhla umemezele ukuthi i-US Food and Drug Administration (FDA) yamukele i-supplementary New Drug Application (sNDA) yenkampani ye-TIBSOVO® (amaphilisi e-ivosidenib) njengendlela yokwelapha engaba khona ezigulini ezine-IDH1-mutated acute myeloid leukemia (AML) engazange iphathwe ngaphambilini. I-sNDA inikezwe i-Priority Review, esheshisa ukubuyekezwa futhi ifinyeze umgomo wesikhathi sokubuyekeza ukusuka ezinyangeni eziyi-10 kuye kwezingu-6. Ukubuyekezwa Okubalulekile ngokuvamile kunikezwa emithini enganikeza intuthuko enkulu ekwelashweni noma engase inikeze ukwelashwa lapho kungekho ukwelashwa okwanele okukhona.
"Ezithendeni zokugunyazwa kwethu kwakamuva kwe-FDA kwe-TIBSOVO ku-cholangiocarcinoma, sijabule ngalesi sinyathelo esibalulekile sokuqhubekela phambili ekucabangeni kwe-ejensi yokwandisa inkomba yayo yamanje ukuze ihlanganise nokwelashwa kweziguli ezine-IDH1-mutated acute myeloid leukemia ngaphambili," kusho uDavid. K. Lee, Isikhulu Esiphethe, i-Servier Pharmaceuticals. “Sijabule ngomfutho omuhle walolu hlelo njengoba siqhubeka nokukhulisa ubuholi bethu ku-oncology futhi silethe eminye imithi eshintsha impilo ezigulini ezinomdlavuza okunzima ukuwelapha.”
Ukwamukelwa kwe-sNDA kusekelwa imiphumela yocwaningo lwe-AGILE, uhlolo lomhlaba wonke, lweSigaba sesi-3 ezigulini ezine-AML eguquliwe ye-IDH1 engazange iphathwe ngaphambilini, eyethulwa ku-2021 American Society of Hematology Annual Meeting and Exposition. Idatha yabonisa ukuthi ukwelashwa nge-TIBSOVO kuhlanganiswe ne-azacitidine kuthuthukisa kakhulu ukusinda ngaphandle kwemicimbi (EFS) (isilinganiso sengozi [HR] = 0.33, 95% CI 0.16, 0.69, 1-sided P = 0.0011 1,2). Ukwengeza, inhlanganisela ye-TIBSOVO ne-azacitidine ibonise ukuthuthukiswa okuphawulekayo kwezibalo ekusindeni okuphelele (OS) (HR = 0.44 [95% CI 0.27, 0.73]; 1-sided P = 0.0005), ene-OS ephakathi yezinyanga ezingu-24.0.
"I-TIBSOVO iyindlela yokwelapha yokuqala eqondiswe ku-metabolism yomdlavuza ukukhombisa ukusinda okuthuthukisiwe kwemicimbi kanye nokusinda okuphelele ngokuhambisana ne-azacitidine ezigulini ezine-AML eguqulwe i-IDH1 engazange iphathwe ngaphambili," kusho uSusan Pandya, MD, iPhini Likamongameli Wezokuthuthukiswa Komtholampilo kanye neNhloko yeCancer Metabolism Global. I-Development Oncology & Immuno-Oncology, I-Servier Pharmaceuticals. "Ngalokhu kwamukelwa kwe-FDA Yokubuyekezwa Okubalulekile, siseduze nokunikeza le nketho yokwelashwa ebalulekile ezigulini zase-US futhi sibheke ngabomvu ukusebenzelana nezinhlaka ezilawulayo emhlabeni jikelele."
I-TIBSOVO[*] okwamanje ivunyelwe e-US njenge-monotherapy ekwelapheni abantu abadala abane-IDH1-mutant relapsed noma i-refractory acute myeloid leukemia (AML), nakubantu abadala abane-IDH1-mutant AML esanda kutholwa abaneminyaka engu-≥75 ubudala noma abanesifo se-IDH1-mutant AML. izifo ezithathelwanayo ezivimbela ukusetshenziswa kwe-intensive induction chemotherapy. Muva nje, i-TIBSOVO iye yagunyazwa njengokwelashwa kokuqala futhi okuhlosiwe kuphela ezigulini ezine-cholangiocarcinoma eguquliwe ye-IDHXNUMX eyalashwa ngaphambilini.
Emzamweni wokuletha izindlela zokwelapha ezintsha ezigulini eziphila nomdlavuza okunzima ukuwelapha, u-Servier wenze i-oncology yaba yinto ehamba phambili emhlabeni wonke, futhi yabela ngaphezu kwama-50% esabelomali sayo socwaningo nentuthuko ocwaningweni lomdlavuza. Njengoba kunezimpahla ezingaphezu kuka-21 ze-oncology ezigabeni ezihlukene zokuthuthuka komtholampilo, kanye namaphrojekthi ocwaningo angama-20 aqhubekayo, u-Servier uzibophezele ekutholeni izisombululo ezibhekana nezidingo zesiguli kulo lonke uhlobo lwezifo kanye nezinhlobo ezahlukahlukene zesimila.
