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Kafukufuku wa Khansa ya Bone Marrow Tsopano Awonjezedwa

CTI BioPharma Corp. lero yalengeza kuti US Food and Drug Administration (FDA) yawonjezera nthawi yowunikira New Drug Application (NDA) ya pacritinib yochizira odwala akuluakulu omwe ali pachiwopsezo chapakati kapena chapakati kapena chachiwiri (post-polycythemia vera. kapena post-essential thrombocythemia) myelofibrosis (MF) yokhala ndi chiwerengero cha maselo a magazi cha <50 × 109/L. Tsiku la Prescription Drug User Fee Act (PDUFA) lawonjezedwa ndi miyezi itatu mpaka pa 28 February 2022.

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Mu kotala yachiwiri ya 2021, a FDA adapereka kuwunika koyambirira kwa CTI's NDA kwa odwala myelofibrosis omwe ali ndi PDUFA deti la Novembara 30, 2021. Mukukambirana zolembera zamalonda, a FDA adapempha zambiri zachipatala, zomwe zidatumizidwa ku bungweli. pa Novembara 24, 2021. M'mbuyomu lero, a FDA adadziwitsa kampaniyo kuti ikuwona kutumizidwa kwa data kukhala "kusintha kwakukulu" kwa NDA ndipo chifukwa chake tsiku la PDUFA lawonjezedwa ndi miyezi itatu kuti ipereke nthawi yowonjezereka kuti iwunikenso zonse. kugonjera. Pakadali pano, CTI sikudziwa zofooka zilizonse pakugwiritsa ntchito.

Pacritinib ndi buku la oral kinase inhibitor lodziwika bwino la JAK2, IRAK1 ndi CSF1R, popanda kuletsa JAK1. NDA idalandiridwa kutengera zomwe zachokera mu Gawo 3 PERSIST-2 ndi PERSIST-1 ndi mayeso achipatala a Phase 2 PAC203, moyang'ana kwambiri odwala omwe ali ndi thrombocytopenic (mapulateleti osakwana 50 x 109/L) omwe adalembetsa nawo maphunzirowa. omwe adalandira pacritinib 200 mg kawiri pa tsiku, kuphatikiza onse omwe ali kutsogolo kwa odwala omwe alibe chithandizo komanso odwala omwe adakumana ndi JAK2 inhibitors. Mu kafukufuku wa PERSIST-2, odwala omwe ali ndi thrombocytopenia yoopsa omwe amathandizidwa ndi pacritinib 200 mg kawiri pa tsiku, 29% ya odwala anali ndi kuchepa kwa ndulu ndi 35%, poyerekeza ndi 3% ya odwala omwe amalandila chithandizo chabwino kwambiri. , zomwe zinaphatikizapo ruxolitinib; 23% ya odwala adachepetsa zizindikiro zonse zosachepera 50%, poyerekeza ndi 13% ya odwala omwe amalandila chithandizo chabwino kwambiri. M'gulu lomwelo la odwala omwe amathandizidwa ndi pacritinib, zochitika zoyipa nthawi zambiri zimakhala zotsika, zoyendetsedwa ndi chisamaliro chothandizira, ndipo nthawi zambiri sizimayambitsa kusiya. Miyezo ya ma platelet ndi hemoglobini nayonso inakhazikika.

Myelofibrosis ndi khansa ya m'mafupa yomwe imayambitsa kupanga minofu ya fibrous scar ndipo ingayambitse thrombocytopenia ndi kuchepa kwa magazi m'thupi, kufooka, kutopa ndi kukula kwa ndulu ndi chiwindi. Ku US kuli pafupifupi odwala 21,000 omwe ali ndi myelofibrosis, 7,000 omwe ali ndi thrombocytopenia yoopsa (yotanthauzidwa ngati kuchuluka kwa mapulateleti ochepera 50 x109/L). Kuopsa kwa thrombocytopenia kumayendera limodzi ndi kusakhala ndi moyo kosakwanira komanso kulemedwa ndi zizindikiro zambiri ndipo kumatha kuchitika chifukwa cha kuchuluka kwa matenda kapena chifukwa cha mankhwala osokoneza bongo ndi zoletsa zina za JAK2 monga JAKAFI ndi INREBIC.

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Linda Hohnholz, mkonzi wa eTN

Linda Hohnholz wakhala akulemba ndi kusintha zolemba kuyambira pomwe anayamba ntchito. Iye wagwiritsa ntchito chilakolako chobadwachi m'malo ngati Hawaii Pacific University, Chaminade University, Hawaii Children's Discovery Center, ndipo tsopano TravelNewsGroup.

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