Chikafu neDrug Administration yakapa kukurumidza kubvumidzwa kune pirtobrutinib (Jaypirca, Eli Lilly uye Kambani) musi waZvita 1, 2023, kune vakuru vane chronic lymphocytic leukemia kana diki lymphocytic lymphoma (CLL/SLL) vakambopfuura mitsara miviri yekutanga yekurapa, kusanganisira BTK inhibitor uye BCL-2 inhibitor.
Chidzidzo ichi chakatarisa kuti chakashanda sei muBRUIN (NCT03740529), yepasirese, yakavhurika-label, single-arm, multicohort kuyedza nevanhu 108 vaive neCLL kana SLL uye vanga vatove nemamwe marapiro maviri, kusanganisira BTK inhibitor uye. BCL-2 inhibitor. Varwere vakawana mitsetse ye5 yapfuura mitsara yerapi, ine huwandu kubva ku2 kusvika ku11. Makumi manomwe nemanomwe muzana evarwere vakamira kushandisa BTK inhibitor yapfuura nekuda kwechirwere chinoramba kana kuwedzera. Mushonga wePirtobrutinib wakapiwa nemuromo pachiyero che 200 mg kamwe chete pazuva uye wakachengetwa kusvikira kufambira mberi kwechirwere kana kutyisa kusingagamuchirwi kwakaitika.
Iwo ekutanga efficacy metrics aive akazara mhinduro mwero (ORR) uye nguva yekupindura (DOR), yakaongororwa nekomiti yakazvimirira yekuongorora yakavakirwa pane 2018 iwCLL maitiro. The target response rate (ORR) yaiva 72% ine 95% nguva yekuvimba (CI) ye63% kusvika 80%, uye nguva yepakati yekupindura (DOR) yaiva 12.2 mwedzi ine 95% CI ye9.3 kusvika ku14.7. Mhinduro dzese dzakanga dzisina kukwana.
Migumisiro yakajairika (≥ 20%), isingasanganisire mazwi ane chekuita nerabhoritari, kwaive kuneta, mavanga, kukosora, kusagadzikana kwetsandanyama, COVID-19, manyoka, mabayo, kurwadziwa nemudumbu, dyspnea, kubuda ropa, edema, kuda kurutsa, pyrexia, uye musoro. Grade 3 kana 4 marabhoritari abnormalities inokanganisa vanopfuura 10% yevarwere yaisanganisira kuderedzwa neutrophil count, anemia, uye kuderera kweplatelet count. 32% yevarwere vakasangana nezvirwere zvakakomba, nezvirwere zvinouraya zvakashumwa mu10% yezviitiko. Zvinyorwa zvekurayira zvinosanganisira yambiro uye kuraira kwehutachiona, kubuda ropa, cytopenias, cardiac arrhythmias, uye anotevera ekutanga cancers.
Iyo yakakurudzirwa yepirtobrutinib dosage ndeye 200 mg inotorwa nemuromo kamwe chete pazuva kusvika kufambira mberi kwechirwere kana mhedzisiro isingagoneki.
Lutetium Lu 177 dotatate inotenderwa neUSFDA kune vana vane makore gumi nemaviri zvichikwira neGEP-NETS.
Lutetium Lu 177 dotatate, kurapwa kwepasi, ichangobva kugamuchira mvumo kubva kuUS Food and Drug Administration (FDA) yevarwere vevana, zvichiratidza chiitiko chakakosha muvana oncology. Mvumo iyi inomiririra chiedza chetariro kuvana vari kurwisana neuroendocrine tumors (NETs), isingawanzowanikwi asi inonetsa yegomarara iro rinowanzoratidza kuti rinoshingirira pakurapa kwakajairika.