Febraayo 2024: Cuntada and Drug Administration has sped up the approval process for two drugs, enfortumab vedotin-ejfv (Padcev, Astellas Pharma) and pembrolizumab (Keytruda, Merck). These drugs are meant to treat people with locally advanced or metastatic urothelial carcinoma who can not get cisplatin-containing chemotherapy.
Waxtarka waxaa lagu qiimeeyay kooxda-badan (koox kordhinta qiyaasta, Kooxda A, Kooxda K) cilmi baarista EV-103/KEYNOTE-869 (NCT03288545). Bukaannada waxaa lagu daweeyay enfortumab vedotin-ejfv + pembrolizumab ee kooxda kordhinta qiyaasta iyo Kooxda A, halka kooxda K, bukaanada loo kala soocay mid ka mid ah isku dhafka ama enfortumab vedotin-ejfv oo keliya. Bukaanku uma qalmin daaweynta kemotherabi ee ay ku jirto cisplatin sababtoo ah hore uma ay marin daawaynta nidaamsan ee jirrooyinka gudaha ka soo baxay ama metastatic. 121 qof ayaa wadar ahaan helay pembrolizumab oo ay weheliso enfortumab vedotin-ejfv.
Heerka jawaabta ujeeddada (ORR) iyo muddada jawaabta (DoR), kuwaas oo lagu go'aamiyay dib u eegista dhexe ee madaxa-bannaan ee indho-la'aanta ah iyada oo la adeegsanayo RECIST v1.1, ayaa ahaa cabbirada natiijada waxtarka ee muhiimka ah. Bukaannada 121, ORR la xaqiijiyay wuxuu ahaa 68% (95% CI: 59, 76), iyadoo 12% bukaannada ay heleen jawaabo buuxa. Kooxda kordhinta qiyaasta iyo Kooxda A waxay lahaayeen dhexdhexaadin DoR ah 22 bilood (kala duwanaansho u dhaxaysa: 1+ ilaa 46+), halka Kooxda K aanay gaadhin dhexdhexaadka DoR (kala duwanaanshaha u dhexeeya: 1 ilaa 24+).
Korodhka gulukooska, kor u kaca aminotransferase aspartate, finan, hoos u dhaca haemoglobin, creatinine oo kordha, neuropathy peripheral neuropathy, lymphocytes oo yaraada, daal, korodhka alanine aminotransferase, hoos u sodium, lipase oo kordha, albumin oo yaraada, alopecia, phosphate hoos u dhac, miisaanka oo yaraada, shuban, cuncun, rabitaanka cuntada oo yaraada Lalabbo, lallabbo, dysgeusia, hoos u dhaca potassium, hoos u dhaca soodhiyamku waxay ahaayeen falcelinta xun ee ugu badan (> 20%), oo ay la socdaan
Marka lagu daro pembrolizumab, qiyaasta lagu taliyey ee enfortumab vedotin-ejfv waa 1.25 mg/kg (ilaa 125 mg bukaanada ka hooseeya 100 kg), oo la siiyo xididada in ka badan 30 daqiiqo maalmaha 1 iyo 8 ee wareegga 21-maalin ilaa cudurku ka sii socdo ama sunta aan loo dulqaadan karin. Ka dib markii la helo enfortumab vedotin isla maalintaas, qiyaasta pembrolizumab waxaa lagula talinayaa in ay noqoto 200 mg saddexdii toddobaadba mar ama 400 mg lixdii toddobaadba mar ilaa uu cudurku ka sii socdo, waxaa jira sun aan loo dulqaadan karin, ama ilaa 24 bilood ka soo wareegtay.
U fiirso macluumaadka daawaynta oo dhan Padcev iyo keytruda.
