Febhuwari 2023: Ukugunyazwa okusheshisiwe kunikezwa yi-FDA ku-pirtobrutinib (Jaypirca, Eli Lilly kanye neNkampani) ye-lymphoma ye-mantle cell ebuyele emuva noma ephikisayo.
E-BRUIN (NCT03740529), isivivinyo se-open-lebel, multicenter, ingalo eyodwa ye-pirtobrutinib monotherapy ehlanganisa iziguli eziyi-120 ze-MCL ezazithole ngaphambilini ukwelashwa kwe-BTK inhibitor, ukusebenza kahle kwahlolwa. Iziguli zazithole i-median yemigqa emithathu yokwelashwa ngaphambilini, kwathi ama-93% athola emibili noma ngaphezulu. I-Ibrutinib (67%), i-acalabrutinib (30%), kanye ne-zanubrutinib (8%), okwakuyizivimbela ze-BTK ezivame ukushiwo ngaphambili, ziye zamiswa ngama-83% eziguli ngenxa yesifo esingaguquki noma esibi kakhulu. I-Pirtobrutinib yanikezwa ngomlomo kanye ngosuku ngesilinganiso se-200 mg futhi yaqhubeka kuze kube yilapho isifo siqhubeka noma imiphumela emibi ingabekezeleleki.
Isilinganiso sokuphendula sisonke (ORR) kanye nobude besikhathi sokuphendula (DOR), njengoba kunqunywe ikomiti elibuyekezayo elizimele lisebenzisa imibandela ye-Lugano, kwakuyizinyathelo eziyinhloko zokusebenza kahle. I-ORR ibingu-50% (95% CI: 41, 59) futhi u-13% wabaphenduli baphothule ucwaningo ngokugcwele. Izinga elilinganiselwe le-DOR ezinyangeni ezingu-6 lilinganiselwa ku-65.3% (95% CI: 49.8, 77.1), kanti i-DOR emaphakathi elinganiselwe yayiyizinyanga ezingu-8.3 (95% CI: 5.7, NE).
Ezigulini ezine-MCL, ukukhathala, ukungakhululeki kwemisipha namathambo, isifo sohudo, i-edoma, i-dyspnea, inyumoniya, kanye nemihuzuko kwakuyimiphumela emibi kakhulu (15%). Ukuncipha kwezibalo ze-neutrophil, i-lymphocyte, ne-platelet kwakuwukungajwayelekile kwelabhorethri yebanga lesi-3 noma lesi-4 ku-10% wabantu. Izinyathelo zokuphepha nezixwayiso eziphathelene nezifo, ukopha, i-cytopenias, i-atrial fibrillation kanye ne-flutter, kanye nezifo eziyingozi zesibili eziyinhloko zifakiwe endabeni yokunquma.
Kunconywa ukuthatha i-200 mg ye-pirtobrutinib kanye ngosuku kuze kube yilapho isifo siqhubeka noma ubuthi bungabekezeleleki.
