Thaum Lub Ib Hlis 16, 2025, IMPACT tshaj tawm tias Senaparib Capsules (派舒宁®） tau txais kev tso cai ua lag luam hauv Suav teb los ntawm National Medical Products Administration (NMPA) ua monotherapy rau kev kho mob rau cov neeg laus uas muaj mob qog nqaij hlav epithelial (FIGO Stages III thiab IV) qib siab ovarian, fallopian tube lossis thawj peritoneal mob qog nqaij hlav uas teb (tag nrho lossis ib nrab) tom qab ua tiav thawj kab platinum-based chemotherapy.
Senaparib, uas IMPACT tau tshawb pom thiab tsim tawm, yog ib qho tshuaj PARP 1/2 inhibitor tshiab thiab muaj zog. Nws cov qauv molecular tshwj xeeb muab nws nrog kev ua haujlwm siab hauv vitro thiab hauv vivo, kev xaiv lub hom phiaj zoo heev thiab lub qhov rais kev nyab xeeb dav. Kev pom zoo yog raws li FLAMES Txoj Kev Kawm. Txoj kev tshawb fawb no yog kev tshawb fawb randomized, ob chav dig muag, placebo-tswj, ntau lub chaw, theem III kev tshawb fawb los ntsuas qhov ua tau zoo thiab kev nyab xeeb ntawm Senaparib ua monotherapy rau kev kho mob ntawm cov neeg mob uas muaj mob qog nqaij hlav zes qe menyuam uas tau ua tiav thawj kab chemotherapy thiab tau txais kev teb tiav (CR) lossis ib nrab teb (PR). Cov txiaj ntsig ntawm FLAMES Txoj Kev Kawm qhia tau hais tias Senaparib tau ua pov thawj tias muaj kev txhim kho tseem ceeb hauv nruab nrab PFS piv rau placebo (PFS tsis tau txog vs 13.6 lub hlis, HR 0.43, P < 0.0001), tsis hais txog BRCA xwm txheej. Senaparib tau ua pov thawj tias muaj kev nyab xeeb txaus, tsis muaj teeb meem kev nyab xeeb pom tseeb. [1] Cov txiaj ntsig kuj qhia tau hais tias ob qho tib si HRD zoo thiab HRD tsis zoo cov pej xeem tau txais txiaj ntsig los ntawm Senaparib kev kho mob, qhia txog lub peev xwm ntawm Senaparib rau kev siv dav dav hauv kev kho mob. Cov txiaj ntsig ntawm txoj kev tshawb fawb no yuav txhawb nqa Senaparib ua tus Txheej Txheem Saib Xyuas rau kev kho mob thawj kab rau cov neeg mob uas nyuam qhuav kuaj pom tias muaj mob qog nqaij hlav zes qe menyuam.
Cov txiaj ntsig zoo tshaj plaws ntawm txoj kev tshawb fawb tau nthuav tawm thawj zaug ua kev nthuav qhia thaum kawg ntawm ESMO hauv xyoo 2023 thiab tau nthuav tawm ntawm CSCO 2024. Thaum Lub Tsib Hlis 15, 2024, phau ntawv xov xwm kho mob nto moo thoob ntiaj teb Nature Medicine kuj tau tshaj tawm cov txiaj ntsig hu ua "Senaparib ua thawj kab kev kho mob hauv kev mob qog nqaij hlav zes qe menyuam: kev sim theem 3."
Mob qog nqaij hlav zes qe menyuam yog ib qho mob qog nqaij hlav uas ua rau poj niam tuag ntau tshaj plaws. Raws li cov ntaub ntawv GLOBOCAN 2020, tus kab mob qog nqaij hlav zes qe menyuam thoob ntiaj teb muaj txog 310,000 tus neeg mob thiab tuag txog 210,000 tus. Raws li cov ntaub ntawv tshiab tshaj plaws ntawm National Cancer Center xyoo 2024, muaj 61,100 tus neeg mob qog nqaij hlav zes qe menyuam tshiab thiab 32,600 tus neeg tuag hauv Suav teb xyoo 2022, ua rau nws yog mob qog nqaij hlav poj niam tuag ntau tshaj plaws. Vim yog cov tsos mob thaum ntxov ntawm mob qog nqaij hlav zes qe menyuam uas tsis tshua muaj thiab tsis tshwj xeeb, kwv yees li 80% ntawm cov neeg mob twb nyob rau theem siab heev thaum lawv kuaj pom, thiab tus nqi ciaj sia nyob 5 xyoos tsuas yog 41.8%. Txawm hais tias mob qog nqaij hlav zes qe menyuam yuav kho tau tom qab thawj zaug siv tshuaj kho mob platinum, feem ntau cov neeg mob yuav ntsib kev rov qab los, thiab tseem muaj kev xav tau kev kho mob tseem ceeb rau cov neeg mob qog nqaij hlav zes qe menyuam.
Tam sim no, tseem muaj ntau qhov kev sim tshuaj kho mob qog noj ntshav tshiab hauv Suav teb nrhiav cov neeg mob. Kev sab laj txog cov tshuaj tshiab thiab cov thev naus laus zis, koj tuaj yeem tiv tauj Beijing South Region Oncology Hospital International Department.
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Cov ntaub ntawv siv los ua piv txwv
Lub sijhawm tshaj tawm: Lub Ob Hlis-18-2025