Nazarin Ciwon Kashi Yanzu Ya Fadada

A KYAUTA Kyauta 2 | eTurboNews | eTN

CTI BioPharma Corp. a yau ta sanar da Hukumar Abinci da Magunguna ta Amurka (FDA) ta tsawaita lokacin bita don Sabuwar Aikace-aikacen Drug (NDA) don pacritinib don kula da manya marasa lafiya tare da matsakaici ko babban haɗarin firamare ko sakandare (bayan polycythemia vera). ko thrombocythemia mai mahimmanci) myelofibrosis (MF) tare da adadin platelet na asali na <50 × 109/L. An tsawaita ranar aiwatar da Dokar Kuɗin Mai Amfani da Magunguna (PDUFA) da watanni uku zuwa 28 ga Fabrairu, 2022.

A cikin kwata na biyu na 2021, FDA ta ba da fifikon bita ga CTI's NDA ga marasa lafiya tare da myelofibrosis tare da kwanan wata PDUFA na Nuwamba 30, 2021. A yayin tattaunawar alamar samfur, FDA ta nemi ƙarin bayanan asibiti, wanda aka ƙaddamar ga hukumar. a kan Nuwamba 24, 2021. Tun da farko a yau, FDA ta sanar da Kamfanin cewa ta yi la'akari da ƙaddamar da bayanan don zama "babban gyara" ga NDA kuma saboda haka an tsawaita ranar PDUFA da watanni uku don samar da ƙarin lokaci don cikakken nazari na sallama. A halin yanzu, CTI ba ta san duk wani babban gazawa a cikin aikace-aikacen ba.

Pacritinib wani labari ne mai hana kinase na baka tare da takamaiman don JAK2, IRAK1 da CSF1R, ba tare da hana JAK1 ba. An yarda da NDA bisa bayanan daga Phase 3 PERSIST-2 da PERSIST-1 da Phase 2 PAC203 gwaje-gwaje na asibiti, tare da mai da hankali kan thrombocytopenic mai tsanani (platelet ƙidaya kasa da 50 x 109 / L) marasa lafiya da suka shiga cikin waɗannan karatun. wanda ya karɓi pacritinib 200 MG sau biyu a rana, gami da duka jiyya na gaba-naive marasa lafiya da marasa lafiya tare da fallasa su ga masu hana JAK2. A cikin binciken PERSIST-2, a cikin marasa lafiya da thrombocytopenia mai tsanani waɗanda aka bi da su tare da pacritinib 200 MG sau biyu a rana, 29% na marasa lafiya sun ragu a cikin ƙananan ƙwayar naman alade na akalla 35%, idan aka kwatanta da 3% na marasa lafiya da ke samun mafi kyawun magani. , wanda ya hada da ruxolitinib; 23% na marasa lafiya sun sami raguwa a cikin jimlar alamun aƙalla 50%, idan aka kwatanta da 13% na marasa lafiya da ke karɓar mafi kyawun maganin da ake samu. A cikin adadin marasa lafiya da aka bi da su tare da pacritinib, abubuwan da ba su da kyau sun kasance gabaɗaya ƙananan ƙima, ana iya sarrafawa tare da kulawar tallafi, kuma da wuya ya haifar da dakatarwa. Hakanan an daidaita adadin platelet da matakan haemoglobin.

Myelofibrosis shine kansar kasusuwa na kasusuwa wanda ke haifar da samuwar tabo mai fibrous kuma zai iya haifar da thrombocytopenia da anemia, rauni, gajiya da kuma kara girma da hanta. A cikin Amurka akwai kusan marasa lafiya 21,000 tare da myelofibrosis, 7,000 daga cikinsu suna da thrombocytopenia mai tsanani (wanda aka ayyana azaman adadin platelet na jini na ƙasa da 50 x109/L). Tsananin thrombocytopenia mai tsanani yana hade da rashin rayuwa mai kyau da babban nauyin alamar cututtuka kuma zai iya faruwa a sakamakon ci gaba da cututtuka ko kuma daga magungunan miyagun ƙwayoyi tare da wasu masu hana JAK2 irin su JAKAFI da INREBIC.

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Avatar na Linda Hohnholz, editan eTN

Linda Hohnholz, editan eTN

Linda Hohnholz tana rubuce-rubuce da gyara labarai tun farkon fara aikinta. Ta yi amfani da wannan sha'awar a wurare kamar su Hawaii Pacific University, Chaminade University, da Hawaii's Discovery Center, da yanzu TravelNewsGroup.

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