Nyem rau qhov no yog qhov no yog koj tshaj tawm!

Kev tshawb fawb ntawm pob txha caj qaum tam sim no txuas ntxiv

CTI BioPharma Corp. hnub no tshaj tawm US Food and Drug Administration (FDA) tau txuas ntxiv lub sijhawm tshuaj xyuas rau Daim Ntawv Thov Kev Siv Tshuaj Tshiab (NDA) rau pacritinib rau kev kho mob ntawm cov neeg laus nrog nruab nrab lossis muaj kev pheej hmoo siab hauv thawj lossis theem nrab (post-polycythemia vera. los yog tom qab qhov tseem ceeb thrombocythemia) myelofibrosis (MF) nrog cov platelet hauv paus suav ntawm <50 × 109 / L. Daim Ntawv Qhia Tshuaj Tus Nqi Siv Tshuaj (PDUFA) hnub ua haujlwm tau txuas ntxiv los ntawm peb lub hlis mus txog Lub Ob Hlis 28, 2022.

Print Friendly, PDF & Email

Hauv lub quarter thib ob ntawm 2021, FDA tau tso cai saib xyuas qhov tseem ceeb rau CTI's NDA rau cov neeg mob myelofibrosis nrog PDUFA hnub tim 30 Kaum Ib Hlis 2021. Nyob rau hauv kev sib tham txog cov khoom lag luam, FDA tau thov cov ntaub ntawv kho mob ntxiv, uas tau xa mus rau lub koom haum Lub Kaum Ib Hlis 24, 2021. Ua ntej hnub no, FDA tau ceeb toom rau Lub Tuam Txhab tias nws txiav txim siab cov ntaub ntawv xa mus los ua "kev hloov pauv loj" rau NDA thiab yog li hnub PDUFA tau txuas ntxiv peb lub hlis los muab sijhawm ntxiv rau kev tshuaj xyuas tag nrho. kev xa. Nyob rau lub sijhawm tam sim no, CTI tsis paub txog qhov tsis zoo hauv daim ntawv thov.

Pacritinib yog ib qho tshiab qhov ncauj kinase inhibitor nrog tshwj xeeb rau JAK2, IRAK1 thiab CSF1R, tsis muaj inhibiting JAK1. NDA tau lees paub raws li cov ntaub ntawv los ntawm Phase 3 PERSIST-2 thiab PERSIST-1 thiab Theem 2 PAC203 kev sim tshuaj, nrog rau kev tsom mus rau qhov hnyav thrombocytopenic (platelet suav tsawg dua 50 x 109 / L) cov neeg mob cuv npe hauv cov kev tshawb fawb no. leej twg tau txais pacritinib 200 mg ob zaug hauv ib hnub, suav nrog ob qho tib si pem hauv ntej kev kho mob-naive cov neeg mob thiab cov neeg mob uas raug cuam tshuam ua ntej rau JAK2 inhibitors. Hauv txoj kev tshawb fawb PERSIST-2, hauv cov neeg mob uas muaj thrombocytopenia hnyav uas tau kho nrog pacritinib 200 mg ob zaug hauv ib hnub, 29% ntawm cov neeg mob tau txo qis cov poov tshuaj tsawg kawg yog 35%, piv rau 3% ntawm cov neeg mob tau txais kev kho zoo tshaj plaws. , uas suav nrog ruxolitinib; 23% ntawm cov neeg mob tau txo qis tag nrho cov tsos mob ntawm tsawg kawg yog 50%, piv rau 13% ntawm cov neeg mob tau txais kev kho zoo tshaj plaws. Hauv tib tib neeg ntawm cov neeg mob kho nrog pacritinib, cov xwm txheej tsis zoo feem ntau yog qib qis, tswj tau nrog kev txhawb nqa, thiab tsis tshua muaj kev cuam tshuam. Platelet suav thiab qib hemoglobin kuj tau ruaj khov.

Myelofibrosis yog mob qog nqaij hlav hauv pob txha uas ua rau tsim cov nqaij caws pliav thiab tuaj yeem ua rau thrombocytopenia thiab ntshav ntshav, tsis muaj zog, qaug zog thiab loj spleen thiab siab. Hauv Teb Chaws Asmeskas muaj kwv yees li 21,000 tus neeg mob uas muaj myelofibrosis, 7,000 ntawm cov uas muaj thrombocytopenia hnyav (txhais tau tias cov ntshav platelet suav tsawg dua 50 x109 / L). Kev mob hnyav thrombocytopenia cuam tshuam nrog kev ciaj sia tsis zoo thiab lub nra hnyav thiab tuaj yeem tshwm sim los ntawm kev kis kab mob lossis los ntawm kev siv tshuaj lom nrog lwm cov tshuaj JAK2 xws li JAKAFI thiab IREBIC.

Print Friendly, PDF & Email

Hais txog qhov kev sau

Linda Hohnholz, tus sau eTN

Linda Hohnholz tau sau thiab kho cov lus txij li thaum pib ua haujlwm. Nws tau thov qhov kev txaus siab uas tsis txaus ntseeg rau qhov chaw xws li Hawaii Pacific University, Chaminade University, Hawaii Children's Discovery Center, thiab tam sim no TravelNewsGroup.

Cia ib saib