Mashi 2024: Ponatinib (Iclusig, Takeda Pharmaceuticals USA, Inc.) uthole imvume esheshayo evela ku-Food and Drug Administration ukuze isetshenziswe ngokuhambisana nokwelashwa ngamakhemikhali ezigulini ezikhulile ezisanda kutholakala ukuthi zine-Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ BONKE).
Ukuphumelela kokwelashwa kwahlolwa esivivinyweni somtholampilo esibizwa nge-PhALLCON (NCT03589326). Lokhu kuhlola kwakuhilela iziguli zabantu abadala ezingama-245 ezazisanda kutholakala zine-Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ BONKE). Ukuhlolwa bekuhleliwe, okusho ukuthi iziguli zabelwa emaqenjini okwelapha ahlukene, futhi bekulawulwa ngokusebenzayo, okusho ukuthi kuqhathanise ukwelashwa okusha nokwelashwa okukhona. Uhlolo lwenzeka ezikhungweni eziningi futhi lwalunelebula elivulekile, okusho ukuthi iziguli nabacwaningi babazi ukuthi isiguli ngasinye sithola luphi ukwelashwa. Izifundo zabelwa ngokungahleliwe (2:1) ukuze zithole i-ponatinib engu-30 mg ngomlomo kanye ngosuku noma i-imatinib engu-600 mg ngomlomo kanye ngosuku kuhlanganiswe nokwelapha ngamakhemikhali (ukusetshenziswa kwe-imatinib ene-chemotherapy akuvunyelwe). Imithi yokwelapha ngamakhemikhali yayihlanganisa imizuliswano engu-3 yokwelashwa kokungeniswa kusetshenziswa i-vincristine ne-dexamethasone, kulandelwa imizuliswano engu-6 yokwelapha okuhlanganisayo eshintshana phakathi kwe-methotrexate ne-cytarabine, futhi ekugcineni imizuliswano engu-11 yokwelashwa kokulungisa kusetshenziswa i-vincristine ne-prednisone. Ngemuva kwesigaba sokungeniswa kanye nokuthola isifo esincane esisele (MRD)-negative complete remission (CR), umthamo we-ponatinib wehliswa waba ngu-15 mg kanye ngosuku.
Ukuphumelela kunqunywe izinga lokukhululwa okuphelele (CR) ngaphandle kwesifo esincane se-residual (MRD) ekupheleni kwesigaba sokungeniswa. Izinga lokuthola ukuxolelwa okuphelele (CR) ngaphandle kwesifo esincane esisele (MRD) ekupheleni kwesigaba sokungeniswa sasingu-30% eqenjini eliphathwe nge-ponatinib kanye ne-12% eqenjini eliphathwe nge-imatinib. Umehluko wengozi phakathi kwamaqembu amabili ubungu-0.18 (95% isikhawu sokuzithemba: 0.08, 0.28), ngevelu engu-p engu-0.0004.
Imiphumela emibi evelele eyabonwa ukungasebenzi kahle kwesibindi, i-arthralgia, ukuqubuka nezimo ezihlobene nakho, ikhanda elibuhlungu, i-pyrexia, ubuhlungu besisu, ukuqunjelwa, ukukhathala, isicanucanu, i-oral mucositis, umfutho wegazi ophakeme, i-pancreatitis/ukuphakama kwe-lipase, i-peripheral neuropathy, ukopha, ukopha, i-febrile neuten i-edema, ukuhlanza, i-paresthesia, ne-arrhythmia yenhliziyo.
Umthamo ophakanyisiwe we-potatinib ngu-30 mg olawulwa ngomlomo kanye ngosuku, ngokuncipha ku-15 mg okulawulwa ngomlomo kanye ngosuku ngemuva kokuthi i-MRD-negative CR ifinyelelwe ekupheleni kwesikhathi sokungeniswa. Qhubeka unikeze i-ponetinib ngokuhambisana ne-chemotherapy kuze kufike imijikelezo engu-20, ngaphandle uma kukhona ukulahlekelwa impendulo noma ukuba khona kobuthi obungabekezeleleki. Ukuthola imininingwane ngama-ejenti omthamo asetshenziswa ngokuhlangana ne-ponatinib, sicela ubheke imininingwane enqunyiwe.
