I-Food and Drug Administration inikeze imvume esheshayo ye-pirtobrutinib (i-Jaypirca, u-Eli Lilly kanye neNkampani) ngoDisemba 1, 2023, kubantu abadala abane-lymphocytic leukemia engapheli noma i-lymphocytic lymphoma encane (CLL/SLL) abaye bathola okungenani imigqa emibili yokwelapha yangaphambilini, kufaka phakathi i-BTK inhibitor kanye ne-BCL-2 inhibitor.
Ucwaningo lubheke ukuthi lusebenze kahle kangakanani e-BRUIN (NCT03740529), isivivinyo somhlaba wonke, selebula evulekile, ingalo eyodwa, i-multicohort enabantu abangu-108 ababene-CLL noma i-SLL futhi asebevele benezinye izindlela zokwelapha okungenani ezimbili, kuhlanganise ne-BTK inhibitor kanye i-BCL-2 inhibitor. Iziguli zithole i-median yemigqa yokwelapha yangaphambilini ye-5, enobubanzi obusuka ku-2 kuya ku-11. Amaphesenti angamashumi ayisikhombisa nesikhombisa eziguli ayeke ukusebenzisa i-BTK inhibitor yangaphambili ngenxa yokugula okuphikisayo noma okubi kakhulu. Umuthi we-Pirtobrutinib wanikezwa ngomlomo ngethamo lika-200 mg kanye ngosuku futhi wawugcinwa kuze kube yilapho kwenzeka ukukhula kwesifo noma ubuthi obungamukeleki.
Amamethrikhi okusebenza ayinhloko bekuyizinga lokuphendula eliphelele (ORR) kanye nobude besikhathi sokuphendula (DOR), esihlolwe ikomidi elibuyekeza elizimele ngokusekelwe kumbandela wokunquma we-iwCLL wango-2018. Izinga lokuphendula elihlosiwe (ORR) lalingu-72% nenkathi yokuzethemba engu-95% (CI) engu-63% kuya ku-80%, kanti ubude besikhathi sokuphendula (DOR) bebuyizinyanga ezingu-12.2 nge-95% CI ye-9.3 kuya ku-14.7. Zonke izimpendulo bezingaphelele.
Imiphumela emibi evame kakhulu (≥ 20%), ingabandakanyi amatemu ahlobene nelabhorathri, kwaba ukukhathala, imihuzuko, ukukhwehlela, ukungakhululeki kwemisipha nohlaka lwamathambo, i-COVID-19, isifo sohudo, inyumoniya, ubuhlungu besisu, ukuphefumula, ukopha, ukuqunjelwa, ukuqunjelwa, isicanucanu, i-pyrexia, kanye ikhanda elibuhlungu. Izinkinga zaselabhorethri zeBanga lesi-3 noma le-4 ezithinta ngaphezu kwe-10% yeziguli zihlanganisa izibalo ezincishisiwe ze-neutrophil, i-anemia, nokuncipha kwezibalo ze-platelet. U-32% weziguli wabhekana nezifo ezinzima, izifo ezibulalayo zibikwa ku-10% wamacala. Izinto ezinqunyiwe zihlanganisa izexwayiso nezeluleko zokutheleleka, ukopha, i-cytopenias, i-cardiac arrhythmias, kanye nomdlavuza oyinhloko olandelayo.
Umthamo ophakanyisiwe we-pirtobrutinib ngu-200 mg othathwa ngomlomo kanye ngosuku kuze kube yilapho isifo siqhubeka noma imiphumela engabekezeleleki.
Cancer
I-Lutetium Lu 177 dotatate igunyazwe yi-USFDA yeziguli zezingane ezineminyaka engu-12 nangaphezulu nge-GEP-NETS
I-Lutetium Lu 177 dotatate, ukwelashwa okuyisimangaliso, isanda kuthola imvume evela kwa-US Food and Drug Administration (FDA) yeziguli zezingane, okumaka ingqopha-mlando ku-oncology yezingane. Lokhu kugunyazwa kumelele ukukhanya kwethemba ezinganeni ezilwa nezimila ze-neuroendocrine (NETs), uhlobo lomdlavuza oluyivelakancane kodwa oluyinselele oluvame ukufakazela ukumelana nemithi evamile.
Alysha Mendossa
Kwangathi 11, 2024
