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Phekolo ea pele e ncha e shebaneng le metabolism ea mofetše

ngotsoeng ke mohlophisi

Kajeno Servier e phatlalalitse hore Tsamaiso ea Lijo le Lithethefatsi ea US (FDA) e amohetse k'hamphani ea tlatsetso ea New Drug Application (sNDA) bakeng sa TIBSOVO® (ivosidenib tablet) e le kalafo e ka bang teng bakeng sa bakuli ba neng ba e-na le IDH1-mutated acute myeloid leukemia (AML) e neng e sa phekoloe pele. sNDA e fuoe Tlhahlobo ea Bohlokoa, e potlakisang tlhahlobo le ho khutsufatsa sepheo sa nako ea tlhahlobo ho tloha likhoeling tse 10 ho isa ho likhoeli tse 6. Tlhahlobo ea Bohlokoa hangata e fuoa meriana e ka fanang ka tsoelo-pele e kholo kalafong kapa e ka fanang ka kalafo moo ho se nang kalafo e lekaneng.             

"Ka mor'a tumello ea rona ea morao-rao ea FDA ea TIBSOVO ho cholangiocarcinoma, re thabetse mohato ona oa bohlokoa oa ho tsoela pele ho nahanoa ke mokhatlo oa ho atolosa pontšo ea hona joale ho kenyelletsa phekolo ea bakuli ba nang le kankere ea mali ea myeloid e neng e sa phekoloe pele e neng e sa phekoloe IDH1," ho boletse David. K. Lee, Mohlanka e Moholo wa Phethahatso, Servier Pharmaceuticals. "Re thabetse ts'ebetso e ntle ea lenaneo lena ha re ntse re tsoela pele ho holisa boetapele ba rona ho oncology le ho fana ka litlhare tse ngata tse fetolang bophelo ho bakuli ba nang le mofetše o thata ho o phekola."

Kamohelo ea sNDA e tšehetsoa ke liphetho tsa thuto ea AGILE, teko ea lefats'e, ea Mokhahlelo oa 3 ho bakuli ba nang le AML e fetotsoeng ea IDH1 e neng e sa phekoloe pele, e ileng ea hlahisoa Kopanong ea Selemo le Selemo ea 2021 ea Mokhatlo oa Amerika oa Hematology. Lintlha li bontšitse hore phekolo ea TIBSOVO hammoho le azacitidine e ntlafalitse haholo ho pholoha ho se nang liketsahalo (EFS) (hazard ratio [HR] = 0.33, 95% CI 0.16, 0.69, 1-sided P = 0.0011 1,2). Ho phaella moo, motsoako oa TIBSOVO le azacitidine o bontšitse ntlafatso ea lipalo-palo ea ho phela ka kakaretso (OS) (HR = 0.44 [95% CI 0.27, 0.73]; 1-sided P = 0.0005), e nang le OS ea bohareng ea likhoeli tse 24.0.

"TIBSOVO ke phekolo ea pele e shebaneng le metabolism ea mofets'e ho bonts'a pholoho e ntlafalitsoeng ntle le liketsahalo le ho phela ka kakaretso hammoho le azacitidine ho bakuli ba neng ba e-na le AML e fetotsoeng ea IDH1 pele e neng e sa phekoloe," ho boletse Susan Pandya, MD, Motlatsi oa Motlatsi oa Motlatsi oa Clinical Development le Hlooho ea Cancer Metabolism Global. Development Oncology & Immuno-Oncology, Servier Pharmaceuticals. "Ka kamohelo ena ea FDA bakeng sa Tlhahlobo ea Bohlokoa, re haufi le ho fana ka khetho ena ea bohlokoa ea kalafo ho bakuli ba US mme re lebelletse ho sebelisana le mekhatlo e laolang lefats'e ka bophara."

TIBSOVO[*] hajoale e amohetsoe US joalo ka kalafo ea monotherapy bakeng sa kalafo ea batho ba baholo ba nang le IDH1-mutant relapsed kapa refractory acute myeloid leukemia (AML), le bakeng sa batho ba baholo ba nang le IDH1-mutant AML ba lilemo tse ≥75 kapa ba nang le lefu la tsoekere. comorbidities tse thibelang tšebeliso ea chemotherapy e matla ea induction. Haufinyane tjena, TIBSOVO e ile ea amoheloa e le phekolo ea pele le e lebisitsoeng feela bakeng sa bakuli ba nang le cholangiocarcinoma e fetotsoeng ea IDH1.

Boitekong ba ho tlisa mekhoa e mecha ea kalafo ho bakuli ba phelang le mafu a mofetše ao ho leng thata ho a alafa, Servier o entse hore oncology e be ntho e tlang pele lefatšeng ka bophara, 'me e abela chelete e fetang 50% ea tekanyetso ea eona ea lipatlisiso le nts'etsopele lipatlisisong tsa mofetše. Ka thepa e fetang 21 ea oncology ka mekhahlelo e fapaneng ea nts'etsopele ea bongaka, le merero ea lipatlisiso tse 20 e ntse e tsoela pele, Servier e ikemiselitse ho fumana tharollo e sebetsanang le litlhoko tsa bakuli ho pholletsa le mefuta eohle ea mafu le mefuta e fapaneng ea hlahala.

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mohlophisi

Mohlophisi e moholo oa eTurboNew ke Linda Hohnholz. O lula ntlong e kholo ea eTN e Honolulu, Hawaii.

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