Astellas Xospata (gilteritinib) Pom zoo: Kev kho tus mob Myeloid Mob Ntshav Qab Zib Nrog FLT3 Kev Sib Hloov!

Astellas tsis ntev los no tshaj tawm tias National Medical khoom Administration (NMPA) ntawm Tuam Tshoj tau txais kev pom zoo los ntawm Xospata® (gilteritinib fumarate ntsiav tshuaj, tomqab no suav tag nrho hu ua gilteritinib) rau kev kho mob ntawm FMS tau kuaj pom muaj kev kuaj pom muaj txiaj ntsig ntawm cov neeg laus uas muaj mob rov huam tuaj (mob rov huam tuaj) lossis refractory (kev kho mob-tiv thaiv) mob myeloid leukemia (AML) nrog kev hloov pauv hauv tyrosine kinase 3 (FLT3).

Hauv Suav teb, gilteritinib xa nws daim ntawv thov kev lag luam hauv lub Peb Hlis 2020, tau NMPA kev soj ntsuam kev tsim nyog tau txais thaum lub Xya Hli, thiab tau suav nrog hauv pawg thib peb uas yuav tsum tau siv tshuaj sai sai rau txawv teb chaws thaum lub Kaum Ib Hlis. Nws yog tam sim no pom zoo nyob rau hauv cov xov xwm nrawm. Mob myeloid mob ntshav dawb (AML) yog cov qog ntshav uas cuam tshuam rau cov ntshav thiab pob txha pob txha, thiab nws cov xwm txheej tshwm sim nrog lub hnub nyoog. AML yog ib qho kev mob siab tshaj plaws hauv cov neeg laus. Kwv yees tias muaj kwv yees li ntawm 80,000 tus neeg tau txheeb xyuas tus neeg muaj ntshav siab ntshav hauv txhua xyoo hauv Suav teb.

Xib fwb Ma Jun, Tus Thawj Coj ntawm Harbin Lub Koom Haum Hematology thiab Tumor, Tuam Tshoj, taw qhia: "Cov neeg mob uas muaj FLT3 hloov pauv nyob rau hauv kev rov tso lossis rov piav qhia AML yog xav tau cov kev kho mob tshiab. Raws li kev pom zoo thawj zaug kev kho mob rau FLT3 hloov pauv nyob rau hauv kev rov tso lossis tso tshuaj AML hauv Suav Teb Cov tshuaj kho mob, gilteritinib, uas tau txais kev pom zoo nyob rau hauv cov xov hluav taws xob ceev, tuaj yeem ua rau cov neeg mob Suav tau txais kev kho mob tshiab sai sai."

Gilteritinib yog lub sijhawm thib ob tiam FLT3 inhibitor, thiab tau pom tias muaj qhov cuam tshuam loj ntawm ob lub FLT3 hloov-FLT3 sab hauv tandem rov ua dua (FLT3-ITD) thiab FLT3 tyrosine kinase domain (FLT3-TKD). Kev hloov pauv FLT3-ITD cuam tshuam txog 30% ntawm cov neeg mob AML, muaj kev pheej hmoo siab rov ua dua thiab txhua lub sijhawm muaj sia nyob ntev dua li cov tsiaj qus hom FLT3. Kev hloov pauv FLT3-TKD cuam tshuam txog li 7% ntawm cov neeg mob AML. Hauv chav kawm ntawm kev kho mob AML, txawm tias tom qab rov qab mob, qhov xwm txheej ntawm FLT3 hloov tau. 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.

Gilteritinib tau pom los ntawm kev sib koom tes tshawb fawb nrog Kotobuki Pharmaceutical. Astellas muaj qhov tshwj xeeb thoob ntiaj teb txoj cai los tsim, tsim khoom, thiab muaj peev xwm ua lag luam hauv Xospata. Hauv tebchaws United States, Nyij Pooj, thiab European Union, Xospata tau tso cai rau chaw muag tshuaj menyuam ntsuag, hauv Tebchaws Meskas tseem tau txais kev tso cai sai, thiab hauv Nyij Pooj tau muab cov npe SAKIGAKE los tsim.

Thaum Lub Kaum Hlis 2018, gilteritinib (Xospata) yog thawj zaug tau txais kev pom zoo hauv Nyij Pooj rau kev kho mob ntawm cov neeg mob neeg laus uas muaj FLT3 hloov pauv nrog kev rov tso lossis rov tso tshuaj AML. Thaum kawg lub Kaum Ib Hlis 2018, gilteritinib (Xospata) tau pom zoo los ntawm Asmeskas FDA raws li thawj FLT3 lub hom phiaj npaj rau cov neeg mob rov qab lossis refractory AML, uas tseem cim Astellas' Kev nkag mus rau kev kho mob qog noj ntshav hauv Tebchaws Meskas. Thaum lub Tsib Hlis 2019, FDA tau pom zoo ntxiv cov ntawv thov tshuaj tshiab (sNDA) rau gilteritinib (Xospata) hloov kho cov khoom lag luam US daim ntawv lo ntawm gilteritinib (Xospata) kom suav nrog cov ntaub ntawv kawg OS los ntawm Theem III ADMIRAL txoj kev sim. Hauv Tebchaws Europe, gilteritinib (Xospata) tau pom zoo rau lub Kaum Hlis 2019 ua ib qho kev kho mob rau cov neeg mob laus uas rov mob lossis rov tuaj dua AML uas nqa FLT3 kev sib hloov (FLT3mut +).

Kev pom zoo hauv Suav teb raws li cov txiaj ntsig ntawm Ntu III ADMIRAL txoj kev tshawb nrhiav, uas tau tshaj tawm hauv New England Journal of Medicine. Cov ntaub ntawv qhia tias hauv cov neeg laus cov neeg mob uas rov mob lossis rov ua dua tshiab FLT3 hloov pauv-zoo AML, kev kho mob gilteritinib ua rau muaj sia nyob ntev (OS) piv nrog kev khaws cia tshuaj (kev nruab nrab OS: 9.3 lub hlis vs 5.6 hli, HR=0.64 [95% CI: 0.49-0.83 ], p=0.0004), ib-xyoo kev muaj sia nyob muaj ob npaug (37% vs 17%), kev kho tiav ntawm tus nqi nrog tag nrho lossis ib nrab hematological rov qab tau ob npaug (34.0% vs 15.3%). Cov ntaub ntawv ntxiv ntawm cov neeg mob cov neeg mob cov neeg mob yog muab los ntawm Theem 3 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 AML uas tau txais tsawg kawg ib koob ntawm 120 mg gilteritinib thiab nqa FLT3 hloov. Cov kev mob tshwm sim tsis zoo tshaj plaws ntawm txhua qib kawm (qhov tshwm sim ≥10%) yog alanine Ntsig tshuaj aminotransferase (ALT) (25.4%), nce aspartate aminotransferase (AST) (24.5%), ntshav tshuaj (20.1%), thrombocytopenia (13.5%), neutropenic kub taub hau (12.5%), platelet tsawg dua (12.2%), mob plab zom mov (12,2%), xeev siab (11.3%), nce phosphatase ntshav alkaline (11%), nkees (10.3%), txo cov qe ntshav dawb (10%) , Thiab nce ntshav creatine phosphokinase (10%). Ntawm cov neeg mob tau txais gilteritinib, 1 rooj plaub ntawm kev phiv tshuaj tiv thaiv mob txawv ua rau tuag. Feem ntau cov kev mob tshwm sim tsis zoo (tshwm sim ≥3%) yog neutropenic ua npaws (7.5%), nce siab 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%).