Na faasilasila e Servier i aso nei ua talia e le US Food and Drug Administration (FDA) le faaopoopoga a le kamupani o le New Drug Application (sNDA) mo TIBSOVO® (ivosidenib tablets) e avea o se togafitiga talafeagai mo tagata mamaʻi e leʻi togafitia IDH1-mutated acute myeloid leukemia (AML). O le sNDA na tu'uina atu le Fa'amuamua Iloiloga, lea e faatelevaveina ai le iloiloga ma fa'apu'upu'u le taimi o iloiloga mai le 10 masina i le 6 masina. Iloiloga Fa'amuamua e masani lava ona tu'uina atu i vaila'au e mafai ona ofoina atu le tele o le alualu i luma i togafitiga po'o le tu'uina atu o se togafitiga pe a leai se togafitiga talafeagai.
"I luga o le mulivae o la matou faʻatagaina talu ai nei a le FDA o TIBSOVO i le cholangiocarcinoma, matou te fiafia i lenei laasaga taua i luma i le iloiloga a le lala sooupu e faʻalauteleina lona faʻamatalaga o loʻo i ai nei e aofia ai togafitiga o tagata mamaʻi e leʻi togafitia IDH1-mutated acute myeloid leukemia," o le tala lea a David K. Lee, Ofisa Sili o Pulega, Servier Pharmaceuticals. "Matou te fiafia lava i le malosi o lenei polokalame aʻo faʻaauau pea le faʻalauteleina o la matou taʻitaʻiga i le oncology ma tuʻuina atu le tele o vailaʻau e suia ai olaga i tagata mamaʻi o loʻo maua i gasegase faigata ona togafitia."
O le taliaina o le sNDA e lagolagoina e faʻaiʻuga mai le suʻesuʻega AGILE, o se faʻataʻitaʻiga faʻavaomalo, Vaega 3 i tagata mamaʻi ma le IDH1-mutated AML e leʻi togafitia muamua, lea na tuʻuina atu i le 2021 American Society of Hematology Annual Meeting and Exposition. O faʻamaumauga na faʻaalia ai o togafitiga faʻatasi ma le TIBSOVO faʻatasi ma le azacitidine na faʻaleleia atili ai le ola e aunoa ma se mea e tupu (EFS) (fuainumera lamatia [HR] = 0.33, 95% CI 0.16, 0.69, 1-itu P = 0.0011 1,2). E le gata i lea, o le tuufaatasiga o le TIBSOVO ma le azacitidine na faʻaalia ai le faʻaleleia atili o fuainumera i le ola atoa (OS) (HR = 0.44 [95% CI 0.27, 0.73]; 1-sided P = 0.0005), faʻatasi ai ma le OS median o 24.0 masina.
"TIBSOVO o le togafitiga muamua lea e faʻatatau i le gasegase o le kanesa e faʻaalia ai le faʻaleleia o le ola e aunoa ma se mea na tupu ma le ola atoa i le tuʻufaʻatasia ma azacitidine i tagata mamaʻi e leʻi togafitia IDH1-mutated AML," o le tala lea a Susan Pandya, MD, Sui Peresetene Falemaʻi Atinaʻe ma Ulu o Cancer Metabolism Global. Atina'e Oncology & Immuno-Oncology, Servier Pharmaceuticals. "Faatasi ai ma lenei taliaina e le FDA mo le Faʻamuamua Iloiloga, ua matou latalata atu i le ofoina atu o lenei filifiliga taua togafitiga i tagata mamaʻi i le US ma matou te tulimatai atu e faʻatasi ma ofisa faʻatonutonu i le lalolagi atoa."
TIBSOVO [*] o loʻo faʻamaonia nei i le US e avea o le monotherapy mo togafitiga o tagata matutua ma le IDH1-mutant relapsed poʻo le refractory acute myeloid leukemia (AML), ma mo tagata matutua e maua i le IDH1-mutant AML e ≥75 tausaga le matutua poʻo i latou ua maua. comorbidities e taofia ai le faʻaaogaina o le chemotherapy induction intensive. Talu ai nei, na faʻamaonia ai le TIBSOVO e avea o se togafitiga muamua ma naʻo le faʻamoemoe mo tagata mamaʻi na togafitia muamua IDH1-mutated cholangiocarcinoma.
I se taumafaiga e aumai ni togafitiga fou mo tagata mama'i o lo'o nonofo i gasegase faigata ona togafitia, ua fa'amuamua ai e Servier le oncology i le lalolagi atoa, ma fa'asoa le sili atu i le 50% o ana su'esu'ega ma le tala fa'atatau o le atina'e i su'esu'ega o le kanesa. Faatasi ai ma le sili atu i le 21 oncology aseta i tulaga eseese o le atinaʻeina o falemaʻi, ma 20 suʻesuʻega poloketi o loʻo faʻaauau, Servier ua tuuto atu i le sailia o fofo e faʻatatau i manaʻoga o tagata maʻi i luga o alaleo atoa o faʻamaʻi ma i ituaiga tumo eseese.
