Tebchaws Asmeskas FDA Pom Zoo Merck Cov Tshuaj Txhuam Hniav Tshuaj Welireg: Kev Kho Mob Ntawm VHL Syndrome ntsig txog Tumors!-1/2

Merck& Tsis ntev los no Co tshaj tawm tias Asmeskas Khoom Noj thiab Tshuaj Yeeb Tshuaj (FDA) tau pom zoo Welireg (belzutifan, txoj cai txhim kho: MK-6482), uas yog hypoxia-inducible factor-2α (HIF-2α) inhibitor, Rau kev kho mob ntawm cov neeg laus nrog Hippel-Lindau syndrome (Von Hippel-Lindau kab mob, VHL syndrome, kab mob VHL), cov neeg mob no tsis tas yuav phais tam sim, xav kho lub raum cell carcinoma (RCC) cuam tshuam nrog VHL syndrome, Hauv nruab nrab lub paj hlwb (CNS) hemangioblastoma, pancreatic neuroendocrine qog (pNET).

Welireg yog thawj qhov kev kho mob HIF-2α pom zoo los ntawm Asmeskas FDA, thiab cov tshuaj tau pom zoo los ntawm cov txheej txheem tshuaj xyuas ua ntej. Yav dhau los, FDA tau tso cai Welireg Kev Txhim Kho Kev Kho Mob (BTD) thiab Kev Tsim Tshuaj Yeeb Tshuaj (ODD). Raws li HIF-2α inhibitor, Welireg tuaj yeem txo qhov kev hloov pauv thiab qhia tawm ntawm HIF-2α cov hom phiaj ntsig txog kev nthuav dav ntawm tes, angiogenesis thiab kev loj hlob ntawm qog. Nws tsim nyog hais tias VHL kev tshawb fawb txog keeb kwm keeb kwm uas coj mus rau kev tshawb pom ntawm HIF-2α yeej qhov khoom plig Nobel hauv Physiology lossis Tshuaj hauv 2019.

Welireg yog cov tshuaj tshiab hauv cov kab mob oncology ntawm Merck. Raws li thawj zaug thiab tsuas yog kev kho mob pom zoo rau kev kho mob ntawm cov neeg mob VHL syndrome, cov tshuaj no tau nthuav dav Merck's oncology portfolio. VHL syndrome yog ib qho kab mob tsawg thiab loj heev uas cuam tshuam nrog kev pheej hmoo mob qog noj ntshav ntau hauv lub cev. Mob qog noj ntshav tseem yog ib lub hauv paus tseem ceeb ntawm kev tuag hauv cov neeg mob VHL syndrome.

Ua ntej Welireg, tsis muaj kev kho mob pom zoo rau kev kho mob VHL ntsig txog qog. Hauv Phase 2 Study-004 txoj kev tshawb fawb, cov neeg mob VHL cuam tshuam nrog cov qog uas kho nrog Welireg pom tias muaj kev tshem tawm ntau thiab tshem tawm tau ntev. FDA' kev pom zoo ntawm Welireg yog ib qib tseem ceeb rau yav tom ntej thiab yuav qhia txog kev kho mob uas muaj peev xwm hloov pauv tus qauv kev kho mob tam sim no rau cov neeg mob uas muaj qee yam ntawm VHL ntsig txog qog.

Hais txog kev siv tshuaj, qhov pom zoo koob tshuaj Welireg (40 mg ntsiav tshuaj) yog 120 mg ib hnub ib hnub kom txog thaum tus kab mob loj zuj zus lossis tsis muaj tshuaj lom tshwm sim. Nws yuav tsum tau sau tseg tias muaj lub thawv dub ceeb toom txuas rau Welireg' daim ntawv lo tshuaj, hais tias cov tshuaj thaum cev xeeb tub tuaj yeem ua rau lub cev xeeb tub puas tsuaj, thiab xwm txheej cev xeeb tub yuav tsum tau txheeb xyuas ua ntej pib noj Welireg. Welireg tuaj yeem ua rau qee yam tshuaj tiv thaiv hormonal tsis ua haujlwm. Cov kws kho mob yuav tsum qhia rau cov neeg mob txog qhov kev pheej hmoo no thaum sau ntawv Welireg thiab xav tau kev tiv thaiv tsis muaj tshuaj tiv thaiv hormonal zoo.

Dr. Scot Ebbinghaus, Tus Lwm Thawj Coj ntawm Kev Tshawb Fawb Kev Tshawb Fawb ntawm Merck Research Laboratories, hais tias:" Welireg yog thawj zaug thiab tsuas yog pom zoo kev kho mob rau cov neeg mob uas muaj hom VHL ntsig txog qog, thiab sawv cev rau kev kho tshiab tseem ceeb rau cov neeg mob cuam ​​tshuam los ntawm tus kab mob no tsawg. Xaiv. Niaj hnub no FDA kev pom zoo ntawm Welireg suav tias yog lub cim tseem ceeb thiab qhia txog Merck txoj kev mob siab rau muab kev kho mob tshiab rau ntau tus neeg mob. "

Kev kawm-004 cov ntaub ntawv tshawb fawb