Servier taa mara ọkwa na US Food and Drug Administration (FDA) anabatala ngwa mgbakwunye ọhụrụ nke ụlọ ọrụ (sNDA) maka TIBSOVO® (mbadamba ivosidenib) dị ka ọgwụgwọ nwere ike maka ndị ọrịa nwere ọrịa leukemia myeloid na-adịghị agwọ ọrịa na mbụ (AML). Enyere sNDA Nlebanya mbụ, nke na-eme ka nyocha ahụ dịkwuo ngwa ma na-ebelata ebumnuche oge nyocha site na ọnwa 1 ruo ọnwa 10. A na-enyekarị nyocha nke mbụ maka ọgwụ ndị nwere ike inye nnukwu ọganihu na ọgwụgwọ ma ọ bụ nwee ike ịnye ọgwụgwọ ebe enweghị ọgwụgwọ zuru oke.
"N'ikiri ụkwụ nke nkwado FDA nke TIBSOVO n'oge na-adịbeghị anya na cholangiocarcinoma, anyị nwere obi ụtọ na nzọụkwụ a dị mkpa na-aga n'ihu na nleba anya nke ụlọ ọrụ ahụ iji gbasaa ihe ngosi ya ugbu a gụnyere ọgwụgwọ nke ndị ọrịa nwere IDH1-mutated nnukwu myeloid leukemia," ka David kwuru. K. Lee, Onye isi nchịkwa, Servier Pharmaceuticals. "Obi dị anyị ụtọ na mmemme a dị mma ka anyị na-aga n'ihu na-eto eto anyị na oncology ma na-ebuga ọtụtụ ọgwụ na-agbanwe ndụ nye ndị ọrịa nwere ọrịa cancer siri ike."
A na-akwado nnabata sNDA site na nsonaazụ sitere na ọmụmụ AGILE, nnwale zuru ụwa ọnụ, usoro 3 na ndị ọrịa nwere IDH1-mutated AML na-agwọbeghị mbụ, nke ewepụtara na 2021 American Society of Hematology Annual Meeting and Exposition. Ihe omuma a gosiputara na ọgwụgwọ na TIBSOVO jikọtara ya na azacitidine mere ka ọ dịkwuo mma ndụ na-enweghị ihe omume (EFS) (ihe ize ndụ [HR] = 0.33, 95% CI 0.16, 0.69, 1-sided P = 0.0011 1,2). Tụkwasị na nke ahụ, nchikota TIBSOVO na azacitidine gosipụtara ọganihu dị ịrịba ama na ndụ zuru ezu (OS) (HR = 0.44 [95% CI 0.27, 0.73]; 1-sided P = 0.0005), na OS etiti nke ọnwa 24.0.
"TIBSOVO bụ ọgwụgwọ mbụ ezubere iche maka metabolism cancer iji gosipụta ndụ na-enweghị ihe omume na ndụ zuru oke yana yana azacitidine na ndị ọrịa nwere IDH1-mutated AML na mbụ," Susan Pandya, MD, Vice President Clinical Development and Head of Cancer Metabolism Global kwuru. Development Oncology & Immuno-Oncology, Servier Pharmaceuticals. "Site na nnabata FDA a maka nyocha izizi, anyị nọ nso ịnye ndị ọrịa nọ na US nhọrọ ọgwụgwọ dị oke mkpa, anyị na-atụkwa anya iso ndị ụlọ ọrụ na-ahụ maka njikwa gburugburu ụwa na-akpakọrịta."
TIBSOVO[*] ka akwadoro ugbu a na US dị ka monotherapy maka ọgwụgwọ ndị okenye nwere IDH1-mutant relapsed ma ọ bụ refractory nnukwu myeloid leukemia (AML), yana maka ndị okenye nwere IDH1-mutant AML ọhụrụ a chọpụtara bụ ndị dị afọ ≥75 ma ọ bụ ndị nwere nsogbu ndị na-egbochi iji chemotherapy induction ike. N'oge na-adịbeghị anya, a kwadoro TIBSOVO dị ka ọgwụgwọ mbụ na nke ezubere iche maka ndị ọrịa nwere IDH1-mutated cholangiocarcinoma na mbụ.
N'ịgbalị iweta nhọrọ ọgwụgwọ ọhụrụ nye ndị ọrịa na-arịa ọrịa kansa siri ike ịgwọ ọrịa, Servier emeela oncology ihe kacha mkpa n'ụwa niile, na-ekenye ihe karịrị 50% nke nyocha ya na mmefu ego mmepe ya na nyocha ọrịa kansa. N'ihe karịrị 21 oncology akụ na ọkwa dịgasị iche iche nke mmepe ụlọ ọgwụ, yana ọrụ nyocha 20 na-aga n'ihu, Servier na-agba mbọ ịchọta ngwọta na-egbo mkpa onye ọrịa n'ofe ụdị ọrịa dị iche iche na ụdị ọrịa dị iche iche.
