Jan 2022: Kune varwere vakura vane nharaunda yepamusoro isinga gadziriswe kana metastatic malignant perivascular epithelioid cell tumours, iyo Food and Drug Administration inopihwa rezinesi. sirolimus mapuroteni-akasungwa zvidimbu zvejekiseni kumiswa (albumin-yakasungwa) (Fyarro, Aadi Bioscience, Inc.) (PEComa).
Kubudirira kwakaedzwa muvarwere ve31 vane nzvimbo yepamusoro isingagadziriswi kana metastatic yakashata PEComa mu AMPECT (NCT02494570), yakawanda, imwe-ruoko rwekliniki yekudzidza. Pamazuva 1 uye 8 ega ega 21-zuva kutenderera, varwere vakagamuchira 100 mg/m2 sirolimus mapuroteni-akasungwa particles kusvikira kufambira mberi kwechirwere kana kusashivirira chepfu.
Kuwanda kwekupindura kwehuwandu (ORR) uye nguva yekupindura (DOR) ndiyo yakakosha yemigumisiro yemigumisiro, sezvakatsanangurwa neyakapofumadzwa yakazvimirira central review uchishandisa RECIST v.1.1. IORR yaiva 39 muzana (95 muzana CI: 22 muzana, 58 muzana), nevarwere vaviri vachipindura zvakakwana. Iyo yepakati DOR haina kusangana (95 muzana CI: 6.5 mwedzi, isingafungidzirwe). 67 muzana yevakapindura vane mhinduro yakatora mwedzi inopfuura 12, uye 58 muzana yakanga ine mhinduro yakatora mwedzi inopfuura 24.
Stomatitis, kuneta, mapundu, utachiona, kuda kurutsa, edoema, manyoka, kusagadzikana kwemisuloskeletal, kuderera kwehuremu, kuderera kwechido, kukosora, kurutsa, uye dysgeusia ndizvo zvaive zvakanyanya kuitika (30 muzana). Kuderera kwe lymphocyte, glucose yakawedzera, potassium yakaderera, yakaderera phosphate, yakadzikira haemoglobin, uye yakakwira lipase ndiyo yainyanya kupararira giredhi 3 kusvika 4 rabhoritari abnormalities (6%).
Kusvikira kufambira mberi kwechirwere kana huturu husingagoneki, iyo inokurudzirwa dosage i100 mg/m2 yakapihwa seIV infusion pamusoro pe30 maminetsi pamazuva 1 uye 8 ega ega 21-zuva kutenderera.
Click this link for full prescribing information for Fyarro.
