Nofeembar 2022: Pemigatinib (Pemazyre, Incyte Corporation) ayaa shati u siisay Maamulka Cuntada iyo Dawooyinka si loogu isticmaalo dadka soo noqnoqday ama soo noqnoqda myeloid/lymphoid neoplasms (MLNs) kuwaas oo leh isbeddelka fayraska koritaanka fibroblast 1 (FGFR1).
FIGHT-203 (NCT03011372), a multicenter open-label, single-arm trial with 28 patients who had relapsed or refractory MLNs with FGFR1 rearrangement, evaluated effectiveness. Patients who met the criteria for eligibility were either ineligible for or had relapsed following allogeneic hematopoietic stem cell transplantation (allo-HSCT) or a disease-modifying treatment (e.g., chemotherapy). Pemigatinib was given until the disease progressed, the toxicity became intolerable, or the patients could receive allo-HSCT.
Shaqsiyaadka la xushay iyo sifooyinka asaasiga ah waxaa ka mid ah kuwan soo socda: 64% dumar ah; 68% cad; 3.6% madow ama Afrikaan Mareykan ah; 11% Aasiyaan; 3.6% Hindida Maraykanka/Dhalad Alaska; iyo 88% heerka waxqabadka ECOG ee 0 ama 1. Da'da dhexe waxay ahayd 65 sano (kala duwan, 39 ilaa 78); 3.6% madow ama Afrikaan Mareykan ah; 68% cad; iyo 68% caddaan.
Iyada oo ku saleysan heerarka jawaab-celinta dhamaystiran (CR) ee buuxisay shuruudaha jawaabta ee gaarka ah nooca jirrada morphologic, waxtarka ayaa la go'aamiyay. 14 ka mid ah 18 ka bukaan ee qaba cudurrada dheeraadka ah (EMD) iyo marxaladda daba-dheeraada ee dhuuxa (78%; 95% CI: 52, 94) waxay heleen cafis dhamaystiran (CR). Celceliska tirada maalmood ee CR waxay ahayd 104. (qiyaastii, 44 ilaa 435). Wakhtiga dhexe (laga bilaabo 1+ ilaa 988+ maalmood) lama gaadhin. Laba ka mid ah afarta bukaan ee ku dhacay marxaladda qarax ee dhuuxa leh ama la'aanteed EMD (mudda: 1+ iyo 94 maalmood) ayaa ku jiray cafis. Mid ka mid ah saddexda bukaan ee EMD kaligiis qabay ayaa la kulmay CR (oo soconaya 64+ maalmood). Heerka jawaabta cytogenetic oo buuxa ee dhammaan bukaannada 28 - oo ay ku jiraan 3 oo aan lahayn cudurka morphologic - wuxuu ahaa 79% (22/28; 95% CI: 59, 92).
Hyperphosphatemia, sunta ciddiyaha, alopecia, stomatitis, shuban, isha qalalan, daal, finan, dhiig-yaraan, calool-istaag, af-engegan, epistaxis, detachment retinal serous, xanuunka xagjirka ah, rabitaanka cuntada oo yaraada, maqaarka qalalan, dyspepsia, dhabar xanuun, lallabbo, aragga oo xumaada. durugsan edoema, iyo dawakhaad ayaa ah kuwa ugu badan (20%) dareen-celinta xun ee bukaanku la kulmaan.
Fosfooraska oo yaraada, lymphocytes oo yaraada, leukocytes oo yaraada, platelet-ka oo yaraada, alanine aminotransferase oo sareeya, iyo neutrophils oo la dhimay ayaa ahaa kuwa ugu badan ee aan caadiga ahayn ee shaybaadhka 3 ama 4 (10%).
Waxaa lagula talinayaa in la qaato 13.5 mg oo pemigatinib hal mar maalintii ilaa uu cudurku ka sii socdo ama ay jirto sun aan loo dulqaadan karin.
View full prescribing information for Pemazyre.
