Musi waChikumi 12-13, FDA yakatendera zviratidzo zviviri zvitsva zvemushonga weK, kwangosara zuva rimwe chete mushonga weK usati watenderwa kurapwa gomarara rechibereko. Rimwe zuva gare gare, US FDA yakabvumidza pembrolizumab (Keytruda, pembrolizumab) kurapwa kwevakuru uye varwere vevana vane refractory primary mediastinal hombe B-cell lymphoma (PMBCL) vanga vadzokera shure mushure memitsara miviri yekurapa.
Kubvumidzwa kwaive kwakavakirwa pane data kubva kuvarwere ve53 vakadzokazve kana kuramba PMBCL kubva kune multicenter, yakavhurika label, imwechete ruoko kutongwa KEYNOTE-170 (NCT02576990). Varwere vakagamuchira 200 mg yePembrolizumab intravenously mavhiki ese e3 kusvika zvisingagamuchirike huturu kana kufambira mberi kwezvirwere, kana kusvika pamwedzi makumi maviri nemana yevarwere vasina kufambira mberi. Iyo yakazara inoshanda mwero ndeye 24%, inosanganisira 45% kuregererwa kwakazara uye 11% kuregererwa zvishoma. Munguva yekutevera-nguva (yepakati yaive mwedzi 34), iyo yepakati yekupindura nguva haina kusvika. Nguva yepakati yemhinduro yekutanga yechinangwa yaive mwedzi 2.8. Pembrolizumab haina kukurudzirwa kune varwere vane PMBCL vanoda emergency emergency tumor.
Muna KEYNOTE-170, maitiro akajairika zvakanyanya muvarwere vane ≥10% PMBCL marwadzo emasculoskeletal, chirwere chepamusoro chekufema, fivha, kuneta, kukosora, dyspnea, manyoka, kurwadziwa kwemudumbu, kuda kurutsa, arrhythmia uye musoro. Pembrolizumab yakamiswa kana kumiswa nekuda kwekukanganisa kwakaipa mu8% uye 15% yevarwere, zvichiteerana. 25% yevarwere vaive nemhedzisiro yekushushikana inoda systemic corticosteroid kurapwa, uye 26% yevarwere vane zvakakomba zvakashata maitiro.
https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm610670.htm