Astellas Gilteritinib Tau NMPA Kev Pom Zoo Los Ntawm Tus Kheej

Thaum Lub Ob Hlis 4, 2021, Astellas Pharmaceutical Group (TSE: 4503) tau tshaj tawm hnub no tias Tuam Tshoj Cov Khoom Siv Tshuaj Kho Mob (NMPA) tau pom zoo XOSPATA® (gilteritinib fumarate ntsiav tshuaj, suav xa mus rau gilteritinib) rau kev siv tshuaj zoo rau kev kuaj mob zoo tau kuaj pom tus mob rov huam mob (rov huam mob tuaj) lossis refractory (kev kho mob tiv thaiv) mob myeloid leukemia (AML) cov neeg laus cov neeg mob FMS zoo li tyrosine kinase 3 (FLT3) hloov pauv. Gilteritinib tau tso cai kev tshuaj xyuas los ntawm National Medical Products Administration ntawm Tuam Tshoj nyob rau lub Xya Hli 2020, thiab tau muab tso rau hauv pob thib peb ntawm kev siv tshuaj kho mob txawv teb chaws thaum lub Kaum Ib Hlis 2020. Nyob rau hauv cov xov xwm nrawm, tam sim no tau pom zoo.

Xib fwb Ma Jun, Tus Thawj Coj ntawm Harbin Lub Koom Haum Hematology thiab Cancer, Tuam Tshoj, taw qhia tawm: "Cov neeg mob uas rov mob lossis rov huam tuaj dua li tus mob myeloid muaj ntshav nrog FLT3 kev hloov pauv sai yog xav tau cov kev kho mob tshiab. Raws li Tuam Tshoj txoj kev pom zoo rau kev kho mob rov qab los yog rov ua haujlwm tshiab FLT3 hloov kho Gilteritinib, lub hom phiaj tshuaj rau cov mob ntshav qab zib, tau txais kev pom zoo nyob rau hauv cov xov hluav taws xob sai, uas ua rau cov neeg mob Suav tau txais kev kho mob sai sai."

Gilteritinib tau pom tias muaj qhov cuam tshuam loj ntawm ob hom ntawm FLT3 hloov pauv, uas yog FLT3 sab hauv tandem duplication (FLT3-ITD) thiab FLT3 tyrosine kinase domain (FLT3-TKD). FLT3-ITD hloov tau cuam tshuam txog 30% ntawm cov neeg mob tus mob myeloid zoo, uas muaj kev pheej hmoo ntxiv rov qab thiab luv dua tag nrho kev ua neej nyob dua li tsiaj qus hom FLT3. Hloov pauv FLT3-TKD cuam tshuam kwv yees li ntawm 7% ntawm cov neeg mob uas mob tus mob myeloid zoo mob ntshav qab zib. Thaum kho mob ntawm tus mob myeloid zoo, txawm tias tom qab rov tshwm sim dua, cov xwm txheej ntawm FLT3 hloov pauv. Yog li, paub tseeb txog cov xwm txheej ntawm tus neeg mob' s FLT3 hloov pauv thaum lub sijhawm rov ua haujlwm yuav pab txiav txim seb qhov tsim nyog thiab lub hom phiaj kho tau zoo.

Professor Wang Jianxiang, tus lwm thawj coj ntawm lub koom haum Hematology, Suav Academy ntawm Medical Sciences tau hais tias: "Kev hloov pauv FLT3 muaj kev cuam tshuam zoo rau kev kwv yees ntawm cov neeg mob uas muaj tus mob myeloid leukemia. Nrog kev txhawb nqa ntawm cov ua tau zoo thiab cov ntaub ntawv muaj kev nyab xeeb, kev siv gilteritinib tau pom zoo, uas yog kev hloov pauv hauv FLT3. Tus naj npawb ntawm cov neeg mob uas rov mob lossis rov huam tuaj yeem mob tus mob myeloid leukemia tau muab ib qho kev xaiv tseem ceeb tshiab."

Professor Wu Depei, tus thawj coj ntawm Hematology Ceg ntawm Tuam Tsev Kho Mob Hauv Suav, tau hais tias:" Kev kuaj mob thiab kev kho mob ntawm hematological malignancies tau loj hlob sai heev nyob rau xyoo tas los no. Daim ntawv thov ntawm ntau yam tshuaj tshiab / kev kho mob tau coj qee yam kab mob, xws li mob qog ua haujlwm thiab myeloma, rau lub sijhawm' tsis muaj tshuaj tua kab mob'. Gilteritinib raug pom zoo rau kev kho mob rov qab lossis rov huam dua myeloid leukemia nrog FLT3 hloov pauv, thiab tseem yuav txhawb txoj kev kho tus mob myeloid tawv nqaij txhawm rau lub sijhawm' tsis muaj tshuaj 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. Nws kwv yees kwv yees li ntawm 80,000 tus neeg hauv Suav teb raug kuaj mob qog ntshav.

Dr. Andrew Krivoshik, Tus Lwm Thawj Coj ntawm Oncology Kev Loj Hlob thiab Taub Hau Kev Kho Mob Thoob Ntiaj Teb ntawm Astellas tau hais tias: Tam sim no lawv tau cawm lawv txoj sia tom qab siv tshuaj khomob. Lub sijhawm nruab nrab cov ciaj sia nyob qis dua 6 lub hlis. Kev pom zoo sai ntawm gilteritinib yog qhov tseem ceeb hauv kev muab cov kev kho mob tshiab rau cov kws kho mob hauv Suav thiab cov neeg mob. Astellas tau cog lus los tsim txoj hauv kev tshiab rau cov qog lub hlwb tsis tshua muaj kev kho mob tau txais kev pom zoo ntawm gilteritinib hauv Suav teb yog ib feem ntawm peb txoj kev mob siab ua haujlwm, thiab peb tos ntsoov rau nws.

Cov kev pom zoo saum toj no yog ua raws li cov txiaj ntsig ntawm Theem III ADMIRAL txoj kev sim, uas tau tshaj tawm hauv New England Journal of Medicine. Piv nrog rau cov neeg mob uas tau txais kev kho mob khaws cia, kev kho mob gilteritinib tuaj yeem ua kom ntev tag nrho kev muaj sia nyob (OS). Qhov nruab nrab muaj txoj sia nyob ntawm cov neeg mob kho gilteritinib yog 9.3 lub hlis, thaum cov neeg mob tau txais kev kho mob khaws cia yog 5.6 lub hlis [piv rau qhov phom sij=0.64 (95% CI 0.49, 0.83), P=0.0004]. Cov ntaub ntawv tshuaj ntxiv ntawm cov neeg mob rau cov neeg mob hauv Suav teb yog muab los ntawm Theem III COMMODORE kev sim, uas tseem tau tshuaj xyuas.

Kev nyab xeeb ntawm gilteritinib raug soj ntsuam hauv 319 cov neeg mob uas rov mob lossis rov huam dua myeloid leukemia uas tau txais tsawg kawg ib koob tshuaj tiv thaiv 120 mg ntawm gilteritinib ib hnub thiab nqa FLT3 hloov pauv 11. Cov kev mob tshwm sim feem ntau (tshwm sim ≥ 10%) ntawm txhua qib kawm tom qab tau txais gilteritinib yog alanine aminotransferase (alanine aminotransferase, ALT) nce (25.4%), aspartate aminotransferase (aspartate aminotransferase, AST nce) siab (24.5%), ntshav tsis txaus (20.1) %), thrombocytopenia (13.5%), neutropenic ua npaws (12.5%), platelet tsawg (12.2%), mob plab zawv (12,2%), xeev siab (11.3%)), nce ntshav alkaline phosphatase (11%), qaug zog (10.3%) ), txo cov qe ntshav dawb (10%), thiab cov ntshav creatine phosphokinase (10%). Ib kis tau tshwm sim hauv cov neeg mob tau txais gilteritinib phiv tshuaj tiv thaiv kev phom sij txawv ua rau tuag. Feem ntau cov kev mob tshwm sim tsis zoo (tshwm sim idence 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 kev phiv loj heev ntawm kev kho mob qhov tseem ceeb suav nrog QT ncua sijhawm ntev ntawm electrocardiogram (0.9%) thiab thim rov qab posterior encephalopathy syndrome (0.3%). %).

Txog Gilteritinib

Gilteritinib yog cov tshuaj pom los ntawm kev tshawb nrhiav kev koom tes los 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 EU thiab lwm lub tebchaws thiab thaj chaw, thiab yog siv los kho cov neeg mob laus uas muaj mob rov huam los yog thim rov qab mob tus mob myeloid leukemia nqa FLT3 kev sib hloov. Cov.

Gilteritinib yog FMS-zoo li tyrosine kinase 3 (FLT3) inhibitor, uas muaj qhov cuam tshuam loj ntawm FLT3-ITD thiab FLT3-TKD kev hloov pauv. FLT3-ITD yog ib qho kev hloov pauv ntawm cov neeg tsav tsheb, uas ua rau lub nra hnyav thiab mob tsis zoo.