Otsuka anticancer tshuaj Inqovi (cedazuridine + decitabine) tau pom zoo los ntawm Asmeskas FDA!

Tsoom Fwv Teb Chaws Asmeskas Khoom Noj thiab Tshuaj (Tsis ntev los no) tau pom zoo rau lub qhov ncauj sib txuam nrog cov tshuaj anticancer Inqovi (cedazuridine / decitabine, qhov ncauj C-DEC, ASTX727) ntawm Astex Pharmaceuticals, uas yog tus tswv lag luam ntawm lub tuam txhab Japanese Otsuka Phamra. Cov tshuaj no yog siv los kho cov neeg mob laus nrog myelodysplastic syndrome (MDS) thiab mob myelomonocytic leukemia (CMML).

Qhov kev pom zoo no yog qhov kev hloov kho tseem ceeb rau kev kho mob rau MDS cov neeg mob uas yav tas los xav tau mus rau hauv lub tsev kho mob rau kev kho cov tshuaj decitabine rau txoj kev kho mob. Hais txog kev siv tshuaj, Inqovi noj rau ntawm lub plab khoob, ib hnub ib zaug, ib ntsiav tshuaj ib zaug, rau 5 hnub sib law liag (thawj 1-5 hnub ntawm txhua lub hlis), thiab txhua 28 hnub yog lub voj voog.

Nws yog tsim nyog teev tias Inqovi yog thawj qhov ncauj hypomethylation npaj tau pom zoo hauv Tebchaws Asmeskas rau kev kho mob ntawm MDS thiab CMML. Inqovi' s daim ntawv thov tshuaj tshiab tau txais FDA kev tshuaj xyuas ua ntej. Ua ib feem ntawm Orbis project, FDA tau koom tes nrog cov phooj ywg los ntawm cov chaw sawv cev thoob ntiaj teb los tshuaj xyuas daim ntawv thov no. Yav dhau los, FDA tau tso cai rau Inqovi Orphan Chaw Tsim Tshuaj Tshuaj (ODD) rau kev kho MDS thiab CMML.

Inqovi (cedazuridine 100mg / decitabine 35mg, cov tshuaj noj hauv qhov ncauj) yog muaj cov koob cedazuridine dhau los (ib qho cytidine deaminase inhibitor) thiab decitabine (kev pom zoo los tiv thaiv mob qog nqaij hlav cancer DNA demethylation Tshuaj) tsim los ntawm kev kho lub qhov ncauj tshiab. Ntawm lawv, cedazuridine tivthaiv tuaj yeem tiv thaiv cytidine deaminase hauv cov hnyuv thiab nplooj siab thiab zam kom tsis txhob muaj kev cuam tshuam ntawm decitabine, yog li ua rau Inqovi ua tiav qhov ncauj tswj hwm ntawm decitabine, uas yog sib npaug rau cov leeg ntshav ntawm decitabine Raug Kev sib npaug.

Inqovi' s kev pom zoo rau kev ua lag luam yuav nqa cov kev xaiv kev kho mob tshiab rau cov neeg mob MDS thiab CMML, txo lawv lub nra ntawm cov dej ntws mus rau 5 hnub hauv ib hlis.

Richard Pazdur, MD, Tus Thawj Coj ntawm FDA Center for Cancer Excellence thiab Tus Thawj Coj Ua Haujlwm ntawm Lub Chaw Haujlwm Oncology thiab Kab Mob ntawm FDA Center rau Kev Tshuaj Ntsuam Xyuas thiab Tshawb Nrhiav Tshuaj, hais tias:" kev mob kis thoob qhov txhia chaw tshiab tshiab (COVID-19). Ntawm No Hauv tsab ntawv pom zoo no, FDA yuav muab cov phiaj xwm kho mob rau cov neeg mob qhov ncauj, uas tuaj yeem txo cov kev mus ntsib tsev kho mob ntau zaus. Lub sijhawm tseem ceeb heev no, peb tseem yuav mob siab rau nrhiav cov kev xaiv rau cov neeg mob qog noj ntshav, suav nrog kev kho mob uas tuaj yeem nqa tom tsev."

Qhov kev pom zoo no yog ua raws cov txiaj ntsig tau zoo ntawm Kev Kawm Phase III ASCERTAIN txoj kev kawm. Qhov no yog tsab ntawv qhib, qhib-sau, hla kev tshawb hauv 138 tus neeg mob nrog MDS thiab CMML uas yav dhau los tsis tau txais kev kho mob (kev kho mob thaum xub thawj) thiab tau txais kev kho mob (kev kho mob). Hauv txoj kev tshawb nrhiav, hauv thawj 2 zaug kev voj voog, cov neeg mob tau txais lub luag hauj lwm kom tau txais qhov ncauj Inqovi (ib zaug ib hnub rau 5 hnub sib law liag, 28 lub hlis ib zaug) lossis txoj hlab ntshav ntawm decitabine (decitabine IV, 20 mg / m2, ib zaug ib hnub, 1h txhua zaus, 5 hnub sib law liag, 28 hnub raws li lub voj voog). Los ntawm lub voj voog thib peb, txhua tus neeg mob tau noj Inqovi ntawm qhov ncauj.

Cov txiaj ntsig tau pom tias txoj kev tshawb no tau mus txog qhov kawg: qhov ncauj Inqovi regimen thiab qhov tso ntshav ntawm decitabine yog qhov sib npaug ntawm tag nrho thaj chaw hauv qab nkhaus ntawm 5 hnub ntawm decitabine (AUC) (qhov piv yog kwv yees li 99%), uas yog 2 Daim phiajcim no muaj qhov cuam tshuam sib luag ntawm decitabine (ntshav siab). Ib qho ntxiv, kwv yees li ib nrab ntawm cov neeg mob uas yav tas los cia siab rau cov ntshav tsis tau ntxiv ntshav rau hauv 8 lub lim tiam.

Hauv qhov kev tshawb fawb no, Inqovi' s kev nyab xeeb zoo ib yam li tso quav ntshav ntawm decitabine. Thaum thawj 2 zaug mus ncig, tsis muaj qhov sib txawv ntawm qhov tshwm sim ntawm qhov tshwm sim ntau tshaj plaws ntawm qhov ncauj Inqovi thiab cov leeg ntshav ntawm decitabine. Qee qhov kev tshwm sim ntawm Inqovi suav nrog kev nkees, cem quav, los ntshav, mob nqaij, mob mucositis (mob rau qhov ncauj), mob sib koom tes, xeev siab, thiab ua npaws nrog cov ntshav dawb tsawg. Inqovi tuaj yeem tsim kev puas tsuaj rau tus menyuam hauv plab, thiab nws raug nquahu tias cov txiv neej thiab poj niam cov neeg mob hnub nyoog yug menyuam siv sijhawm tiv thaiv kom zoo.