Sab nraum ntawm Lub Tsev Haujlwm Saib Xyuas Khoom Noj thiab Tshuaj tau pom hauv White Oak, Md.
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Pawg Neeg Saib Xyuas Khoom Noj thiab Tshuaj rau hnub Thursday tau pom zoo tawm tsam kev pom zoo tag nrho ntawm kev kho mob qog noj ntshav uas tsim los ntawm Innovent Biologics thiab Eli Lilly txog kev txhawj xeeb txog qhov kev sim tshuaj tau ua nyob rau hauv Suav teb hauv cov neeg koom uas tsis muaj ntau haiv neeg li Asmeskas cov pej xeem.
FDA's Oncologic Drugs Advisory Committee, hauv kev pov npav 14 rau 1, tau hais tias cov tuam txhab yuav tsum ua cov kev sim tshuaj ntxiv uas cuam tshuam txog Asmeskas cov neeg mob ua ntej lawv tau txais kev pom zoo zaum kawg. Kev kho mob monoclonal antibody, sintilimab, kho cov neeg laus uas tsis yog mob qog noj ntshav hauv lub ntsws nrog rau kev kho mob.
Pawg neeg saib xyuas FDA tau hais tias qhov kev sim ntawm cov txiv neej Asian feem ntau tsis sawv cev rau ntau haiv neeg ntawm Asmeskas cov neeg mob, ua rau nws nyuaj rau txiav txim siab seb cov txiaj ntsig puas yuav tuav ntawm no.
Cov neeg mob uas tsim mob qog noj ntshav hauv Asmeskas tau faib sib npaug ntawm poj niam txiv neej thiab muaj ntau haiv neeg keeb kwm. Cov neeg mob hauv txoj kev tshawb no kuj tseem hluas thiab tsawg dua yog cov neeg haus luam yeeb tam sim no lossis yav dhau los piv nrog cov neeg uas mob qog noj ntshav hauv Asmeskas
"Lub sijhawm thaum FDA thiab kev lag luam tab tom sim ua kom muaj ntau haiv neeg hauv kev sim tshuaj xyuas kom ntseeg tau tias lawv yog cov neeg sawv cev ntawm cov neeg mob yuav tsum tau kho, nws tsis muaj kev nkag siab tias yuav txav mus rau qhov tsis sib xws nrog daim ntawv thov no," said David Mitchell, ib pawg neeg thiab tus tsim ntawm Cov Neeg Mob rau Cov Tshuaj Muaj Nqis.
Dr. Richard Pazdur, tus thawj coj ntawm FDA's Oncology Center of Excellence, tau hais txog qhov tseem ceeb ntawm kev sim tshuaj ntsuam xyuas thoob plaws ntau lub tebchaws kom ntseeg tau tias lawv muaj kev cuam tshuam txog kev ntxub ntxaug lwm haiv neeg. Nws hais tias lub hom phiaj tsis suav nrog Tuam Tshoj, tab sis coj nws mus rau thoob ntiaj teb kev txhim kho tshuaj.
Pazdur tau hais tias "Kev xa ib lub tebchaws yog ib kauj ruam rov qab los ntawm kev ua tiav cov haiv neeg sib txawv uas peb xav tau hauv Tebchaws Meskas," Pazdur tau hais.
Dr. Lana Shiu, tus thawj coj ntawm kev tswj hwm kev tswj hwm ntawm Innovent, hais tias sintilimab tau txais txiaj ntsig zoo thiab pom muaj txiaj ntsig zoo rau cov neeg mob tawm tsam ntau hom qog nqaij hlav. Dr. David Ferry, lub taub hau ntawm kev kho mob oncological ntawm Eli Lilly, hais tias haiv neeg thiab lub cev hnyav tsis muaj txiaj ntsig cuam tshuam rau kev ua haujlwm ntawm sintilimab.
Cov tswvcuab kuj tau hais tias qhov kev sim no ua tsis tau raws li FDA cov qauv kev pom zoo pom zoo vim nws tsis tau qhia meej meej txog kev kho mob nrog kev pom zoo kho lossis koom nrog lwm txoj kev tshawb fawb.
"Txawm hais tias kev ncaj ncees cov ntaub ntawv tseem ceeb tshaj plaws hauv kev tshawb fawb soj ntsuam, kev ncaj ncees kev ncaj ncees yog qhov tseem ceeb dua," said Dr. Ravi Madan, tus thawj coj kho mob ntawm National Cancer Institute. Madan tau hais tias daim ntawv tso cai pom zoo tsis tau hloov kho raws li xav tau thaum lub sijhawm sim.
Cov tuam txhab tseem tsis tau sab laj nrog FDA los ntawm tag nrho cov chaw kuaj mob. Txoj kev tshawb no tau pib thaum Lub Yim Hli 2018 tab sis FDA tsis tau ceeb toom txog lub Plaub Hlis 2020, thaum cov tuam txhab xa lawv cov txiaj ntsig thiab hais tias lawv npaj yuav thov kev pom zoo.
Dr. Jorge Garcia, tus kws kho mob qog noj ntshav tau hais tias "Kuv poob siab thaum hnov qhov tsis muaj kev koom tes ntawm tus neeg thov kev pab thiab tus neeg txhawb nqa thaum ntxov ntawm kev sim tsim," Dr. "Kuv xav ntseeg tias yog tias cov rooj sib tham no tau tuav, tej zaum peb yuav tsis muaj qhov kev sib tham no."
Dr. Harpreet Singh, tus thawj coj hauv FDA's Office of Oncologic Diseases, tau hais tias cov neeg tshawb xyuas lub chaw haujlwm tau tshuaj xyuas ob qhov chaw thaum lub sijhawm sim thiab pom tias muaj kev ceeb toom tsis zoo ntawm cov xwm txheej tsis zoo. Singh tau hais tias cov neeg ua haujlwm sim tau raug cob qhia txog qhov tseem ceeb ntawm kev khaws ntaub ntawv zoo los tiv thaiv cov teeb meem yav tom ntej.
Dr. Jorge Nieva tsis pom zoo thaum lub sijhawm pov ntawv xaiv tsa, hais tias cov tshuaj ua haujlwm thiab muab txiaj ntsig rau cov neeg mob piv rau kev siv tshuaj khomob ib leeg. Nieva tau hais tias txawm hais tias muaj lwm yam tshuaj mob ntsws ntsws hauv khw, kev pom zoo ntau dua yuav pab txo tus nqi thiab txhim kho kev nkag mus rau ntau tus neeg mob.
"Peb tsis muaj pov thawj tias cov ntaub ntawv nthuav tawm tsis muaj kev ntseeg siab, hluavtaws lossis lwm yam dag," Nieva, tus kws kho mob qog noj ntshav thiab tus xibfwb ntawm Keck School Medicine ntawm University of Southern California. "Peb muaj kev tshuaj xyuas FDA txaus uas tsis muaj kev cuam tshuam. Yog xav tau kev tshuaj xyuas ntxiv, nws cia siab tias FDA yuav tau ua lawv, "nws hais.
Tau qhov twg los: https://www.cnbc.com/2022/02/10/fda-committee-votes-against-eli-lilly-cancer-treatment-over-concerns-trials-conducted-only-in-china.html