Laga bilaabo Diseembar 15, 2023, Maamulka Cuntada iyo Dawooyinka (FDA) ayaa ansixiyay enfortumab vedotin-ejfv (Padcev, Astellas Pharma) oo ay la socdaan pembrolizumab (Keytruda, Merck) loogu talagalay dadka uu ku dhacay kansarka kaadi mareenka kaadi-mareenka (la/mUC). FDA waxay hore si degdeg ah u siisay oggolaanshahan isku-dhafka ah ee bukaannada qaba kansarka kaadi mareenka ee horumarsan ama metastatic ee aan heli karin daawaynta cisplatin ku jirta.
Daraasadu waxay eegtay sida ugu wanaagsan ee ay uga shaqeysay EV-302/KN-A39 (NCT04223856), tijaabo calaamad furan oo aan kala sooc lahayn oo leh 886 qof oo hore u maray kansarka kaadi mareenka kaadi mareenka oo aan hore u helin wax daaweyn nidaamsan oo jirro sare leh. Bukaannada waxaa si aan kala sooc lahayn loo siiyay enfortumab vedotin-ejfv oo leh pembrolizumab ama kiimiko ku salaysan platinum (gemcitabine oo leh cisplatin ama carboplatin midkood). Kala soocida ayaa loo kala saaray iyadoo lagu salaynayo u-qalmitaanka cisplatin, muujinta PD-L1, iyo jiritaanka beerka beerka.
Tallaabooyinka waxtarka leh ee aasaasiga ah waxay ahaayeen badbaadada guud (OS) iyo badbaadada-horumar la'aanta (PFS) oo ay qiimeeyeen koox dhexdhexaad ah oo dhexdhexaad ah.
Enfortumab vedotin-ejfv iyo pembrolizumab waxay muujiyeen horumarro la taaban karo oo la taaban karo ee guud ahaan badbaadada (OS) iyo badbaadada horumarka-free (PFS) marka la barbar dhigo daawaynta ku salaysan platinum. Badbaadinta guud ee dhexdhexaadka ah waxay ahayd bilaha 31.5 (95% CI: 25.4, aan la qiyaasi karin) bukaanada lagu daaweeyay enfortumab vedotin-ejfv oo lagu daray pembrolizumab, iyo 16.1 bilood (95% CI: 13.9, 18.3) ee kuwa lagu sameeyay kiimiko ku salaysan platinum. Saamiga khatarta wuxuu ahaa 0.47 (95% CI: 0.38, 0.58) oo leh p-qiimaha ka yar 0.0001. Badbaadada dhexdhexaadka ah ee dhexdhexaadka ah (PFS) waxay ahayd 12.5 bilood (95% CI: 10.4, 16.6) ee bukaanada lagu daaweeyay enfortumab vedotin-ejfv iyo pembrolizumab, iyo 6.3 bilood (95% CI: 6.2, 6.5) kuwa lagu sameeyay platinum-ka kiimoterabi ku salaysan. Saamiga khatarta (HR) wuxuu ahaa 0.45 (95% CI: 0.38, 0.54) oo leh p-qiimo ka yar 0.0001.
Dareen-celinta xun ee ugu badan (≥20%) lagu arkay bukaanada lagu daweeyay enfortumab vedotin-ejfv marka lagu daro pembrolizumab waxaa ku jira cillado shaybaar oo kala duwan sida aminotransferase aspartate oo kordhay, creatinine oo kordhay, finan, glucose oo kordhay, neuropathy peripheral, lipase kordhay, lymphocytes oo yaraaday, alanine aminotransferase, hoos u hemoglobin, daal, hoos u soodhiyam, fosfooraska hoos u dhaca, hoos u albumin, cuncun, shuban, alopecia, miisaanka oo yaraada, rabitaanka cuntada oo yaraada, Urate kordhay, neutrophils hoos u, potassium hoos u dhaca, isha qalalan, lallabo, calool-istaagga, potassium kordhay, dysgeusia. , caabuqa kaadi mareenka, iyo platelets oo yaraada.
Qiyaasta la soo jeediyay ee enfortumab vedotin-ejfv oo ay weheliso pembrolizumab waa 1.25 mg/kg (ilaa 125 mg bukaanada miisaankoodu yahay 100 kg ama ka badan) oo la siiyay faleebo xididka ah oo soconaysa 30 daqiiqo maalmaha 1 iyo 8 ee wareegga 21 maalmood ilaa horumarka cudurka ama waxyeellooyin aan loo dulqaadan karin.
Qiyaasta la soo jeediyay ee pembrolizumab marka lagu daro enfortumab vedotin-ejfv waa 200 mg oo la siiyo faleebo xididka 3 asbuuc kasta ama 400 mg 6dii asbuucba ilaa uu cudurku ka sii socdo, suntan aan loo dulqaadan karin, ama laba sano oo daaweyn ah.
Kansarka
Lutetium Lu 177 dotatate waxa ansixisay USFDA bukaanada carruurta 12 sano iyo ka weyn ee GEP-NETS
Lutetium Lu 177 dotatate, oo ah daawayn hor leh, ayaa dhawaan ogolaansho ka heshay Maamulka Cunnada iyo Dawooyinka ee Maraykanka (FDA) ee bukaanada carruurta, taas oo calaamad u ah guul muhiim ah oo ku saabsan kansarka carruurta. Oggolaanshahani waxa uu u taagan yahay iftiin rajo u ah carruurta la dagaallamaysa burooyinka neuroendocrine (NETs), oo ah nooc naadir ah laakiin adag oo kansar ah kaas oo inta badan caddeeya u adkaysiga daaweynta caadiga ah.
Alysha Mendossa
Waxaa laga yaabaa 11, 2024
