Fabrairu 2024: Abincin da Drug Administration ya hanzarta aiwatar da amincewar magunguna guda biyu, enfortumab vedotin-ejfv (Padcev, Astellas Pharma) da pembrolizumab (Keytruda, Merck). Ana nufin waɗannan magungunan don kula da mutanen da ke da ci gaba a cikin gida ko kuma ciwon daji na urothelial na metastatic waɗanda ba za su iya samun chemotherapy mai ɗauke da cisplatin ba.
An ƙididdige inganci a cikin ƙungiyoyi masu yawa (ƙungiyar haɓakar kashi, Cohort A, Cohort K) bincike EV-103/KEYNOTE-869 (NCT03288545). An yi wa marasa lafiya magani tare da enfortumab vedotin-ejfv + pembrolizumab a cikin ƙungiyar haɓaka kashi da Cohort A, yayin da a cikin Cohort K, an keɓance marasa lafiya zuwa ko dai haɗin gwiwa ko enfortumab vedotin-ejfv kadai. Marasa lafiya ba su cancanci yin amfani da ilimin chemotherapy wanda ke ɗauke da cisplatin ba saboda ba a taɓa yin magani na yau da kullun ba don ci gaban gida ko rashin lafiya. Mutane 121 gabaɗaya sun sami pembrolizumab tare da enfortumab vedotin-ejfv.
Maƙasudin mayar da martani (ORR) da tsawon lokacin amsawa (DoR), waɗanda aka ƙaddara ta hanyar nazari na tsakiya mai zaman kansa mai zaman kansa ta amfani da RECIST v1.1, sune mahimman matakan sakamako na inganci. A cikin marasa lafiya 121, ORR da aka tabbatar shine 68% (95% CI: 59, 76), tare da 12% na marasa lafiya suna samun cikakkiyar amsa. Ƙungiya ta haɓaka adadin adadin da Cohort A tana da matsakaicin DoR na watanni 22 (kewayon tsaka-tsaki: 1+ zuwa 46+), yayin da ƙungiyar K ba ta kai matsakaicin DoR ba (kewayon tsaka-tsaki: 1 zuwa 24+).
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Lokacin da aka haɗa tare da pembrolizumab, shawarar da aka ba da shawarar na enfortumab vedotin-ejfv shine 1.25 mg / kg (har zuwa 125 MG ga marasa lafiya a ƙarƙashin 100 kg), ana ba da su ta cikin jini sama da mintuna 30 akan Ranaku 1 da 8 na sake zagayowar kwanaki 21 har sai cutar ta ci gaba ko rashin jurewa guba. Bayan shan maganin enfortumab vedotin a wannan rana, ana ba da shawarar adadin pembrolizumab ya zama 200 MG kowane mako uku ko 400 MG kowane mako shida har sai cutar ta ci gaba, akwai guba maras iya jurewa, ko kuma har zuwa watanni 24 sun wuce.
