Thandizo loyamba latsopano lolunjika pa khansa metabolism

Servier lero adalengeza kuti US Food and Drug Administration (FDA) yavomereza kampani yowonjezera ya New Drug Application (sNDA) ya TIBSOVO® (mapiritsi a ivosidenib) ngati chithandizo chotheka kwa odwala omwe anali ndi IDH1-mutated acute myeloid leukemia (AML) sNDA idapatsidwa Kuwunika Kwambiri, komwe kumathandizira kuwunikiranso ndikufupikitsa cholinga cha nthawi yobwereza kuyambira miyezi 10 mpaka miyezi 6. Kuunika Kwambiri Kwambiri nthawi zambiri kumaperekedwa kwa mankhwala omwe angapereke chitsogozo chachikulu pamankhwala kapena angapereke chithandizo chomwe palibe chithandizo chokwanira.             

"Pambuyo pa chivomerezo chathu chaposachedwa cha FDA cha TIBSOVO mu cholangiocarcinoma, tili okondwa ndi gawo lofunikirali pakulingalira kwa bungweli kuti liwonjezere zomwe zikuwonetsa kuti ziphatikizepo chithandizo cha odwala omwe anali ndi IDH1-mutated acute myeloid leukemia," adatero David. K. Lee, Chief Executive Officer, Servier Pharmaceuticals. "Ndife okondwa ndi mayendedwe abwino a pulogalamuyi pomwe tikupitiliza kukulitsa utsogoleri wathu pazamankhwala a oncology ndikupereka mankhwala osintha moyo kwa odwala omwe ali ndi khansa yovuta kuchiritsa."

Kuvomereza kwa sNDA kumathandizidwa ndi zotsatira za kafukufuku wa AGILE, kuyesedwa kwapadziko lonse, Phase 3 kwa odwala omwe kale anali ndi IDH1-mutated AML, omwe anaperekedwa ku 2021 American Society of Hematology Annual Meeting and Exposition. Deta inasonyeza kuti mankhwala ndi TIBSOVO osakaniza azacitidine kwambiri bwino zochitika-free kupulumuka (EFS) (ngozi chiŵerengero [HR] = 0.33, 95% CI 0.16, 0.69, 1-mbali P = 0.0011 1,2). Kuphatikiza apo, kuphatikiza kwa TIBSOVO ndi azacitidine kunawonetsa kusintha kwakukulu pakupulumuka (OS) (HR = 0.44 [95% CI 0.27, 0.73]; 1-mbali P = 0.0005), yokhala ndi OS yapakatikati ya miyezi 24.0.

"TIBSOVO ndiye njira yoyamba yochizira matenda a khansa kuwonetsa kukhala ndi moyo wopanda zochitika komanso kupulumuka kwathunthu kuphatikiza azacitidine mwa odwala omwe anali ndi IDH1-mutated AML," atero a Susan Pandya, MD, Wachiwiri kwa Purezidenti Clinical Development ndi Mutu wa Cancer Metabolism Global. Development Oncology & Immuno-Oncology, Servier Pharmaceuticals. "Ndikuvomereza kwa FDA Kuwunika Kwambiri Kwambiri, tatsala pang'ono kupereka njira yovutayi kwa odwala ku US ndipo tikuyembekeza kuyanjana ndi mabungwe olamulira padziko lonse lapansi."

TIBSOVO[*] pano ndiyovomerezeka ku US ngati monotherapy yothandizira akuluakulu omwe ali ndi IDH1-mutant relapsed kapena refractory acute myeloid leukemia (AML), komanso kwa akuluakulu omwe ali ndi matenda a IDH1-mutant AML omwe ali ndi zaka ≥75 zakubadwa kapena omwe adwala comorbidities zomwe zimalepheretsa kugwiritsa ntchito kwambiri induction chemotherapy. Posachedwapa, TIBSOVO idavomerezedwa ngati chithandizo choyambirira komanso chokhacho chomwe chimaperekedwa kwa odwala omwe adalandirapo kale mankhwala a IDH1-mutated cholangiocarcinoma.

Poyesa kubweretsa njira zatsopano zothandizira odwala omwe ali ndi khansa zovuta kuchiza, Servier wapanga oncology kukhala yofunika kwambiri padziko lonse lapansi, ndipo amagawira ndalama zoposa 50% za kafukufuku wake ndi chitukuko ku kafukufuku wa khansa. Ndi katundu wopitilira 21 wa oncology pamagawo osiyanasiyana azachipatala, komanso ma projekiti 20 akupitilira, Servier akudzipereka kupeza mayankho omwe amakwaniritsa zosowa za odwala pamitundu yonse ya matenda komanso mitundu yosiyanasiyana ya chotupa.