Kubva muna Zvita 15, 2023, iyo Food and Drug Administration (FDA) yakabvumidzwa enfortumab vedotin-ejfv (Padcev, Astellas Pharma) pamwe na pembrolizumab (Keytruda, Merck) kune vanhu vane munharaunda yepamusoro kana metastatic urothelial carcinoma (la/mUC). Iyo FDA yakambopa mvumo yekukurumidza kune iyi musanganiswa kune varwere vane munharaunda yepamusoro kana metastatic urothelial carcinoma vasingakwanise kuwana cisplatin-ine kurapwa.
Chidzidzo ichi chakatarisa kuti chakashanda zvakanaka sei muEV-302/KN-A39 (NCT04223856), muyedzo wakasarudzika, wakavhurika-chinyorwa nevanhu mazana masere nemakumi masere nevatanhatu vaive nenharaunda yepamusoro kana metastatic urothelial carcinoma uye vanga vasati vawana kurapwa kwehurongwa hwehurwere hwepamusoro kare. Varwere vakapihwa zvisina tsarukano ingave enfortumab vedotin-ejfv ine pembrolizumab kana platinamu-based chemotherapy (gemcitabine ine cisplatin kana carboplatin). Randomization yakakamurwa zvichienderana nekukodzera kwecisplatin, PD-L886 kutaura, uye kuvepo kwechiropa metastases.
Matanho ekutanga ekushanda aive ekurarama kwese (OS) uye kufambira mberi-kusina kupona (PFS) yakaongororwa neasina divi repakati rekuongorora timu pasina rusaruro.
Enfortumab vedotin-ejfv plus pembrolizumab yakaratidza kuvandudzwa kwakakosha mukupona kwese (OS) uye kufambira mberi-kusina kupona (PFS) zvichienzaniswa neplatinamu-based treatment. Kupona kwepakati pese kwaive mwedzi 31.5 (95% CI: 25.4, isingafungidzirwe) kune varwere vakarapwa neenfortumab vedotin-ejfv pamwe pembrolizumab, uye 16.1 mwedzi (95% CI: 13.9, 18.3) kune avo vakawana chemotherapy-based chemotherapy. Huwandu hwengozi hwaive 0.47 (95% CI: 0.38, 0.58) ine p-value isingasviki 0.0001. Kurarama kwepakati-pasina kurarama (PFS) kwaive mwedzi gumi nemaviri (12.5% CI: 95, 10.4) kune varwere vakarapwa neenfortumab vedotin-ejfv pamwe nepembrolizumab, uye mwedzi 16.6 (6.3% CI: 95, 6.2) kune avo vakaita platinum- based chemotherapy. The hazard ratio (HR) yaiva 6.5 (0.45% CI: 95, 0.38) ine p-value isingasviki 0.54.
Kunyanya kushata (≥20%) kunoonekwa muvarwere vanorapwa neenfortumab vedotin-ejfv pamwe chete nepembrolizumab kwaisanganisira zvakasiyana-siyana zverabhoritari zvakadai sekuwedzera aspartate aminotransferase, kuwedzera creatinine, rash, kuwedzera glucose, peripheral neuropathy, kuwedzera lipase, kuderera kwe lymphocytes, yakawedzera alanine aminotransferase, yakaderera hemoglobin, kuneta, yakaderera sodium, yakaderera phosphate, yakaderera albumin, pruritus, manyoka, alopecia, kuderera kwehuremu, kuderera kwechido, kuwedzera urate, kuderera neutrophils, kuderedza potassium, ziso rakaoma, kusvotwa, kuvimbiswa, kuwedzera potassium, dysgeusia. , chirwere cheweti, uye kuderera kweplatelet.
Muyero unofungidzirwa weenfortumab vedotin-ejfv wakasanganiswa nepembrolizumab i1.25 mg/kg (kusvika 125 mg kune varwere vane huremu hwe100 kg kana kupfuura) wakapihwa semutsinga unotora maminitsi makumi matatu paMazuva 30 ne1 emazuva makumi maviri nerimwe kusvika. kufambira mberi kwechirwere kana migumisiro isingagoneki.
Chiyero chinokurudzirwa chepembrolizumab kana chasanganiswa neenfortumab vedotin-ejfv i200 mg inopihwa kuburikidza nekupinda mutsinga mavhiki matatu ega ega kana 3 mg masvondo matanhatu ega ega kusvika chirwere chakura, chepfu isingashiviriki, kana makore maviri ekurapwa.
kenza
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.
Alysha Mendossa
Dai 11, 2024
