Astellas Gilteritinib ntsiav tshuaj rau kev kho mob leukemia tau mus txog rau qhov pib qhov kawg

Thaum Lub Peb Hlis 30, 2021, Astellas Pharmaceutical Group tau tshaj tawm hnub no tias XOSPATA® (Gilteritinib) yog siv los kho tus mob (rov mob huam tuaj) lossis rov kho dua tshiab (tiv thaiv kev kho mob) cov neeg mob uas muaj kev hloov pauv FLT3 (FLT3mut +) Lub sijhawm III pom zoo kev sim tshuaj mob rau cov neeg laus cov neeg mob myeloid leukemia (AML), hauv kev txheeb xyuas ua ntej, piv nrog kev khaws cia tshuaj, tau mus txog thawj qhov kawg ntawm kev ciaj sia tag nrho (OS).

Kev sib hais plaub COMMODORE yog qhov kev ua haujlwm ntau qhov qhib kev tshawb xyuas kev tshawb fawb uas tau tshawb pom nyob hauv Suav teb thiab lwm lub tebchaws los sib piv cov kev ua tau zoo ntawm Gilteritinib txoj kev kho thiab khaws cia tshuaj rau hauv cov neeg laus cov neeg mob rov mob lossis refractory FLT3 mutant AML. Astellas tau tso npe tsis koom rau hauv qhov kev sim no thiab yuav muab sijhawm rau cov neeg mob pab pawg kho mob yuav muaj sijhawm tau txais kev kho Gilteritinib.

Nyuam qhuav pib lub xyoo no, Tuam Tshoj National Medical khoom Administration (NMPA) tau pom zoo los ntawm Gilteritinib rau kev kho mob lossis rov ua dua qhov FMS zoo li tyrosine kinase 3 (FLT3) kev hloov pauv tau tshawb pom los ntawm kev kuaj pom tseeb. Cov neeg laus uas mob refractory mob myeloid leukemia (AML). Gilteritinib tau txais kev tshuaj xyuas kev saib xyuas kev muaj feem ua ntej ntawm NMPA thaum Lub Xya Hli 2020, thiab tau muaj nyob rau hauv pob thib peb ntawm cov chaw kho mob xav tau sai sai rau cov tshuaj tshiab txawv teb chaws thaum lub Kaum Ib Hlis 2020, thiab tau txais kev pom zoo nyob rau hauv cov xov xwm nrawm.

Astellas npaj xa COMMODORE' s cov txiaj ntsig kev xeem rau Tuam Tshoj National Medical Products Administration kom tau txais kev pom zoo ua ntej rau kev lag luam. Cov ncauj lus kom ntxaws tseem yuav muab xa mus rau cov neeg muaj hnub nyoog sib tham nrog kev soj ntsuam thiab / lossis cov rooj sib tham tshawb fawb.

Dr Andrew Krivoshik, Tus Lwm Thawj Coj ntawm Oncology Kev Loj Hlob thiab Thoob Ntiaj Teb lub taub hau ntawm Kev Kho Kab Mob ntawm Astellas hais tias:" Qhov txiaj ntsig no Qhov no siv tau qhov muaj txiaj ntsig kev kho mob tau pom nyob rau Theem III ADMIRAL kev sim siab rau tag nrho cov kev muaj sia nyob. Rau cov neeg mob uas tsis muaj cov kev kho mob tsawg, cov txiaj ntsig tshiab pom cov pov thawj ntxiv rau Gilteritinib ua qhov kev xaiv kho."

Mob myeloid yog cov qog ntshav uas cuam tshuam rau cov ntshav thiab mob pob txha, thiab nws cov tshwm sim muaj hnub nyoog nce ntxiv. Mob myeloid caj dab yog ib hom mob leukemias uas ib txwm muaj rau cov neeg laus. Khwv yees tias tam sim no muaj ntau tshaj li 85,000 tus neeg mob ntshav siab mob ntshav hauv Suav teb hauv ib lub xyoo.

Hauv kev sim ua ntej, kev nyab xeeb ntawm Gilteritinib raug soj ntsuam hauv 319 cov neeg mob uas rov mob lossis rov huam dua tuaj yeem mob (nrog rau FLT3 hloov) uas tau txais tsawg kawg ib koob tshuaj Gilteritinib 120 mg / hnub. Gilteritinib' s qhov muaj ntau tshaj plaws (qhov tshwm sim ≥ 10%) ntawm txhua qib ntawm qhov tsis zoo yog alanine aminotransferase (alanine aminotransferase, ALT) nce (25.4%), aspartate aminotransferase (aspartate aminotransferase, AST nce (24.5)%), kev mob ntshav (20.1%), thrombocytopenia (13.5%), neutropenic ua npaws (12.5%), txo cov ntshav txhaws (12.2%), mob plab zom mov (12,2%), xeev siab (11.3%), ntshav ntxiv alkaline phosphatase (11%), qaug zog ( 10.3%), txo cov qe ntshav dawb (10%), thiab cov ntshav creatine phosphokinase (10%). Hauv cov neeg mob tau txais Gilteritinib, ib qhov teeb meem tuag-tshwm sim muaj Kev Nyuaj Siab Nyuaj Siab Sib Txawv. Cov kev mob tshwm sim uas hnyav tshaj (tshwm sim inc 3%) yog neutropenic ua npaws (Febrile Neutropenia, 7.5%) thiab nce alanine aminotransferase (ALT) (3.4%), Thiab aspartate aminotransferase (AST) nce (3.1%). Lwm qhov teeb meem loj uas yuav tshwm sim rau kev kho mob, suav nrog electrocardiogram QT ntu nyob ntev (0.9%) thiab thim rov qab posterior encephalopathy syndrome (0.3%).

Txog Gilteritinib

Gilteritinib yog cov tshuaj pom los ntawm kev tshawb fawb kev sib koom tes ntawm Astellas thiab Kotobuki Pharmaceutical Co., Ltd. Astellas muaj txoj cai tshwj xeeb los tsim, tsim khoom thiab ua lag luam Gilteritinib thoob ntiaj teb. Gilteritinib (lub npe lag luam: XOSPATA®) tau nkag mus rau cov neeg mob hauv tebchaws Meskas, Nyij Pooj, qee lub tebchaws hauv European Union, thiab lwm lub tebchaws thiab thaj chaw rau kev kho mob rau cov neeg mob laus uas muaj mob rov huam los yog rov mob siab dua myeloid leukemia nqa FLT3 kev hloov pauv. Gilteritinib yog FMS-zoo li tyrosine kinase 3 (FLT3) inhibitor, uas muaj qhov cuam tshuam loj ntawm FLT3-ITD (ib qho kev hloov pauv ntawm cov neeg tsav tsheb uas qhia tias muaj kev phom sij tsis zoo thaum lub load siab) thiab FLT3-TKD hloov. FLT3-ITD yog ib qho kev hloov pauv ntawm cov neeg tsav tsheb, ua rau muaj kev cuam tshuam txog kev mob hnyav thiab kev kuaj mob tsis zoo