I-CTI BioPharma Corp. ibhengeze i-US Food and Drug Administration (i-FDA) ivume i-VONJO (i-pacritinib) yonyango lwabantu abadala abaphakathi okanye abanomngcipheko ophezulu okanye wesibini (i-post-polycythemia vera okanye i-post-essential thrombocythemia) i-myelofibrosis ene-platelet count. ngaphantsi kwe50 × 109/L. I-VONJO iyinoveli ye-oral kinase inhibitor eneenkcukacha ezithile ze-JAK2 kunye ne-IRAK1, ngaphandle kokuthintela i-JAK1. Idosi ecetyiswayo ye-VONJO yi-200 mg ngomlomo kabini yonke imihla. I-VONJO yonyango lokuqala oluvunyiweyo olujongene ngqo neemfuno zezigulane ezine-cytopenic myelofibrosis.
"Namhlanje ukuvunyelwa kwe-VONJO kumisela umgangatho omtsha wokunyamekela izigulane ze-myelofibrosis eziphethwe yi-cytopenic myelofibrosis," watsho uJohn Mascarenhas, MD, uNjingalwazi oNxibeleleyo, i-Medicine, i-Hematology kunye ne-Oncology yezoNyango, i-Tisch Cancer Institute, i-Icahn School of Medicine kwiNtaba yeSinayi, eNew York. . "I-Myelofibrosis ene-thrombocytopenia enzima, echazwa ngokubala kweplatelet yegazi ngaphantsi kwe-50 × 109 / L, ibonakaliswe ukuba ibangele iziphumo ezibi zokusinda kunye neempawu eziphazamisayo. Iinketho zonyango ezinqongopheleyo zinike esi sifo njengendawo yemfuno engxamisekileyo yonyango. Kuyandivuyisa ukubona ukuba unyango olutsha, olusebenzayo nolukhuselekileyo luyafumaneka ngoku kwezi zigulana.”
"E-US, kukho malunga ne-21,000 yezigulane ezine-myelofibrosis, isibini kwisithathu sazo ezine-cytopenias (i-thrombocytopenia okanye i-anemia), edla ngokubangelwa yityhefu yolunye unyango oluvunyiweyo. I-thrombocytopenia enzima, echazwa njengenani leplatelet yegazi ngaphantsi kwe-50 × 109 / L, lenzeka kwisithathu sesithathu sabantu bonke be-myelofibrosis, kwaye i-prognosis imbi kakhulu. Ngokuvunywa kwe-VONJO, siyavuya kuba ngoku sikwazi ukubonelela ngonyango olutsha oluvunywe ngokukodwa kwizigulane ezine-cytopenic myelofibrosis. Sixhaswa ngemali ngokupheleleyo ukuze siqalise urhwebo, silandela amatyala ethu kunye nokuthengiselana kwasebukhosini nge-DRI, kwaye sijonge phambili ekuboneleleni nge-VONJO, olona nyango lunokuba lukumgangatho ophezulu kwizigulana ze-cytopenic myelofibrosis, kwizigulana kwiintsuku ezili-10, utshilo u-Adam R. Craig. , MD, Ph.D., uMongameli kunye noMlawuli oyiNtloko we-CTI Biopharma. “Ndingathanda ukubulela izigulana, abanonopheli, abasebenzi bolingo lwezonyango kunye nabaphandi abenze ukuba ulingo lwezonyango lwe-VONJO lwenzeke. Ndikwabulela neqela leCTI ngokusebenza nzima nokuzinikezela kunye nokugxila kwabo kwiimfuno zezigulana. "
Ukuvunywa okukhawulezileyo kusekelwe kwiziphumo ezisebenzayo ezivela kwiSigaba esibalulekileyo se-3 PERSIST-2 isifundo se-VONJO kwizigulane ezine-myelofibrosis (i-platelet ibala ngaphantsi okanye ilingana ne-100 × 109 / L). Izigulane zahlelwa nge-1: 1: 1 ukufumana i-VONJO 200 mg kabini imihla ngemihla (BID), VONJO 400 mg kanye ngosuku (QD) okanye unyango olufumanekayo (BAT). Ngaphambi kokuba unyango lwe-inhibitor lwe-JAK2 luvunyelwe. Kulo cwaningo, kwiqela lezigulane ezineeplatelet ezisezantsi ezingaphantsi kwe-50 × 109 / L eziphathwe nge-pacritinib 200 mg BD, i-29% yezigulane ziye zanciphisa umthamo we-spleen ubuncinane ubuncinane be-35% xa kuthelekiswa ne-3% yezigulane ezifumanayo. olona nyango lukhoyo, oluquka i-ruxolitinib. Njengenxalenye yokuvunywa okukhawulezileyo, i-CTI iyafuneka ukuba ichaze inzuzo yeklinikhi kulingo lokuqinisekisa. Ukuzalisekisa le mfuneko yasemva kokuvunywa, iCTI iceba ukugqibezela ulingo lwePACIFICA, ngeziphumo ezilindelekileyo phakathi ku-2025.
Ezona mpendulo zixhaphakileyo zixhaphakileyo (≥20%) ezilandela i-VONJO 200 mg kabini imihla ngemihla yayisisirhudo, i-thrombocytopenia, isicaphucaphu, i-anemia kunye ne-peripheral edema. Ezona mpendulo zixhaphakileyo ziyingozi (≥3%) ezilandela i-VONJO 200 mg kabini yonke imihla ibe yi-anemia, i-thrombocytopenia, inyumoniya, ukungaphumeleli kwentliziyo, ukuqhubela phambili kwesifo, ipyrexia kunye ne-squamous cell carcinoma yolusu.
INTO ONOKUYITHATHA KWELI NQAKU:
- In this study, in the cohort of patients with baseline platelet counts below 50 × 109/L who were treated with pacritinib 200 mg BD, 29% of patients had a reduction in spleen volume of at least 35% compared to 3% of patients receiving best available therapy, which included ruxolitinib.
- With the approval of VONJO, we are excited to now be able to offer a new therapy that is specifically approved for patients with cytopenic myelofibrosis.
- Food and Drug Administration (FDA) has approved VONJO (pacritinib) for the treatment of adults with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis with a platelet count below 50 × 109/L.
