Erdafitinib waxa u ansixisay USFDA kansarka urothelial urothelial ka horumaray ama metastatic

Erdafitinib (Balversa, Janssen Biotech) waxaa ansixiyay Maamulka Cuntada iyo Dawooyinka Janaayo 19, 2024, loogu talagalay bukaannada qaangaarka ah ee leh isbeddellada hidde-sideyaasha FGFR3 kuwaas oo gudaha u horumaray ama kansarka urothelial metastatic (mUC). Bukaanada uu ku dhacay cudurkooda way ka sii daraan ka dib markii ay heleen ugu yaraan hal daawayn nidaam oo hore ayaa u qalma ansixintan, marka loo eego baaritaanka ogaanshaha saaxiibka ee FDA-ansixisay. Erdafitinib laguma talin in lagu daweeyo bukaanada u qalma oo aan hore loo marin PD-1 ama PD-L1 inhibitor therapy. Oggolaanshahani waxa uu bedelayaa isticmaalkii asalka ahaa ee dadka qaba kansarka urothelial-ka metastatic (mUC) ee leh isbeddello gaar ah oo ku jira hidde-sideyaasha FGFR3 ama FGFR2 waxaana mar hore lagu daweeyay kiimoterabi platinum-ku jira.

Daraasadda BLC3001 Kooxda 1 waxay eegtay sida wanaagsan ee ay u shaqeyso. Waxay ahayd tijaabo sumad furan oo la kala soocay, oo ay la socdeen 266 qof oo qabay kansarka kaadi mareenka ee metastatic (mUC) iyo isbeddellada FGFR3 qaarkood. Bukaannadani waxay soo mareen 1-2 daaweyn hore oo nidaamsan, oo ay ku jiraan PD-1 ama PD-L1 inhibitor. Ka qaybqaatayaasha ayaa si aan kala sooc lahayn loogu qoondeeyay saamiga 1:1 si ay u helaan erdafitinib ama ikhtiyaarka kemotherabi ee uu door biday baaruhu, kaas oo noqon kara docetaxel ama vinflunine. Kala sooc la kala soocayn ayaa la sameeyay iyadoo lagu salaynayo aagga, heerka waxqabadka, iyo dhacdooyinka muuqalka ama lafaha lafaha. 75% bukaanada ku jira shaybaadhka dhexe, therascreen FGFR RGQ RT-PCR kit (Qiagen) ayaa lagu ogaaday isbedelada FGFR3 ee nudaha burada, iyada oo bukaanada soo hadhay ay leeyihiin daraasado isku xigxiga jiilka xiga ee maxalliga ah ayaa helay isbeddelada.

Cabbirka waxtarka aasaasiga ah wuxuu ahaa badbaadada guud (OS). Baadhaha-qiimaynta badbaadada-la'aanta horumarka (PFS) iyo heerka jawaabta ujeeddada (ORR) waxay ahaayeen cabbirro natiijadood oo dheeri ah.

Waxaa jiray horumarro la taaban karo oo la taaban karo oo ku saabsan badbaadada guud (OS), badbaadada aan horumarka lahayn (PFS), iyo heerka jawaabta ujeeddada (ORR) markii erdafitinib loo isticmaalay beddelka kiimoterabiga. Badbaadinta guud ee dhexdhexaadka ah waxay ahayd bilaha 12.1 (95% CI: 10.3, 16.4) ee bukaanada lagu daaweeyay erdafitinib iyo bilaha 7.8 (95% CI: 6.5, 11.1) kuwa helay kiimoterabi. Saamiga khatarta (HR) wuxuu ahaa 0.64 (95% CI: 0.47, 0.88) oo leh p-qiimaha 0.0050. Badbaadinta horumarka dhexdhexaadka ah ee dhexdhexaadka ah waxay ahayd bilaha 5.6 (95% CI: 4.4, 5.7) bukaanada lagu daaweeyay erdafitinib iyo bilaha 2.7 (95% CI: 1.8, 3.7) ee kuwa helay kiimoterabi. Saamiga khatarta wuxuu ahaa 0.58 (95% CI: 0.44, 0.78) oo leh p-qiimaha 0.0002. Heerka jawaabta ujeedada la xaqiijiyay (ORR) waxay ahayd 35.3% (95% CI: 27.3, 43.9) ee bukaanada lagu daaweeyay erdafitinib iyo 8.5% (95% CI: 4.3, 14.6) ee kuwa qaatay kiimoterabiga (p-qiimaha <0.001) ).

Dareen-celinta xun ee ugu badan, oo ku dhacda in ka badan 20% kiisaska, waxaa ka mid ah heerarka fosfooraska oo sarreeya, arrimaha ciddiyaha, shuban, bararka afka, heerarka fosfatase alkaline oo sarreeya, heerarka hemoglobin-ka oo yaraada, heerarka alanine aminotransferase oo sarreeya, heerarka aspartate aminotransferase sare, hoos u dhaca heerka sodium, heerka creatinine oo kordhay, afka engegan, heerka fosfate hoos u dhaca, xaaladda maqaarka oo saamaysa calaacalaha iyo calaacalaha, beddelka dareenka dhadhanka, daal, maqaarka qalalan, calool-istaagga, rabitaanka cuntada oo yaraada, heerka calcium oo kordha, timo lumis, indho qalalan, heerka potassium sare , iyo miisaanka oo yaraada.

Qiyaasta erdafitinib ee la soo jeediyay waa 8 mg oo afka laga qaato hal mar maalintii, iyadoo la kordhin karo 9 mg hal mar maalin kasta ka dib 14 ilaa 21 maalmood iyadoo ku xiran dulqaadka, gaar ahaan hyperphosphatemia. Sii wad daawaynta ilaa uu cudurku ka sii darayo ama waxyeellooyinku noqdaan kuwo aan loo dulqaadan karin.