Pịa ebe a ma ọ bụrụ na nke a bụ ntọhapụ mgbasa ozi gị!

Ọmụmụ ọrịa kansa ụmị ọkpụkpụ agbatịla ugbu a

CTI BioPharma Corp. taa mara ọkwa US Food and Drug Administration (FDA) agbatịwo oge nyochaa maka Ngwa Ọgwụ Ọhụrụ (NDA) maka pacritinib maka ọgwụgwọ nke ndị ọrịa toro eto nwere etiti ma ọ bụ nnukwu ihe ize ndụ nke isi ma ọ bụ nke abụọ (post-polycythemia vera). ma ọ bụ thrombocythemia post-dị mkpa) myelofibrosis (MF) nwere ọnụ ọgụgụ platelet ntọala nke <50 × 109/L. Egbatịla ụbọchị ọrụ iwu ụgwọ onye ọrụ ọgwụ ndenye ọgwụ (PDUFA) site na ọnwa atọ ruo February 28, 2022.

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N'ime nkeji nke abụọ nke 2021, FDA nyere ntụle mbụ maka CTI's NDA maka ndị ọrịa nwere myelofibrosis nwere ụbọchị PDUFA nke Nọvemba 30, 2021. N'ime mkparịta ụka nrịbama ngwaahịa, FDA rịọrọ data nlekọta ahụike ọzọ, nke edobere n'ụlọ ọrụ ahụ. na Nọvemba 24, 2021. Tupu taa, FDA gwara ụlọ ọrụ ahụ na ọ na-atụle ntinye data ka ọ bụrụ "isi mmezi" na NDA na ya mere ụbọchị PDUFA agbatịwo ọnwa atọ iji nyekwuo oge maka nyocha zuru ezu nke nrubeisi. N'oge ugbu a, CTI amaghị maka adịghị ike ọ bụla na ngwa a.

Pacritinib bụ onye na-emechi ọnụ kinase nke nwere nkọwapụta maka JAK2, IRAK1 na CSF1R, na-egbochighị JAK1. A nabatara NDA dabere na data sitere na Phase 3 PERSIST-2 na PERSIST-1 na Phase 2 PAC203 ule ụlọ ọgwụ, na-elekwasị anya na nnukwu thrombocytopenic (platelet na-erughị 50 x 109 / L) ndị ọrịa debanyere aha na ọmụmụ ihe ndị a. onye natara pacritinib 200 mg ugboro abụọ n'ụbọchị, gụnyere ma ọgwụgwọ ihu n'ihu-ndị ọrịa na-enweghị uche na ndị ọrịa nwere tupu ikpughe na JAK2 inhibitors. N'ime ọmụmụ PERSIST-2, na ndị ọrịa nwere thrombocytopenia siri ike bụ ndị a na-emeso pacritinib 200 mg ugboro abụọ n'ụbọchị, 29% nke ndị ọrịa nwere mbelata nke splin olu ma ọ dịkarịa ala 35%, ma e jiri ya tụnyere 3% nke ndị ọrịa na-enweta ọgwụgwọ kachasị mma. , nke gụnyere ruxolitinib; 23% nke ndị ọrịa nwere mbelata na mkpokọta akara ngosi ma ọ dịkarịa ala 50%, ma e jiri ya tụnyere 13% nke ndị ọrịa na-anata ọgwụgwọ kacha mma. N'otu ọnụ ọgụgụ nke ndị ọrịa na-agwọ ọrịa na pacritinib, ihe ọjọọ na-abụkarị ọkwa dị ala, a na-ejikwa ya na nlekọta nkwado, na-adịkarịghị eduga n'ịkwụsị. A kwadokwara ọnụ ọgụgụ platelet na haemoglobin.

Myelofibrosis bụ ọrịa kansa ụmị ọkpụkpụ nke na-ebute mpụta anụ ahụ fibrous ma nwee ike ibute thrombocytopenia na anaemia, adịghị ike, ike ọgwụgwụ na splin na imeju gbasaa. N'ime US enwere ihe dị ka ndị ọrịa 21,000 nwere myelofibrosis, 7,000 n'ime ha nwere thrombocytopenia siri ike (akọwapụtara dị ka ọnụ ọgụgụ platelet ọbara na-erughị 50 x109/L). A na-ejikọta thrombocytopenia siri ike na ndụ na-adịghị mma na ibu mgbaàmà dị elu ma nwee ike ime n'ihi ọganihu ọrịa ma ọ bụ site na ọgwụ ọjọọ na ndị ọzọ na-emechi JAK2 dị ka JAKAFI na INREBIC.

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Banyere chepụtara

Linda Hohnholz, onye editọ eTN

Linda Hohnholz na-ede ma na-edezi isiokwu kemgbe ọ malitere ọrụ ya. O tinyela obi uto nke a dika ebe Hawaii Pacific University, Chaminade University, Hawaii Discovery Center, ma ugbu a TravelNewsGroup.

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