USFDA ta amince da Erdafitinib don ci-gaban gida ko ciwon daji na urothelial metastatic

Erdafitinib (Balversa, Janssen Biotech) Hukumar Abinci da Magunguna ta amince da ita a ranar 19 ga Janairu, 2024, don manya marasa lafiya tare da canje-canjen kwayoyin halittar FGFR3 waɗanda suka sami ci gaba a cikin gida ko ƙwayar cuta ta urothelial (mUC). Marasa lafiyan da suka kamu da cutar nasu sun yi muni bayan sun karɓi aƙalla magani na tsarin gaba ɗaya sun cancanci wannan amincewa, bisa ga gwajin gwajin abokin tarayya da FDA ta amince. Ba a ba da shawarar Erdafitinib don kula da marasa lafiya waɗanda suka cancanci yin amfani da su ba kuma ba a yi amfani da su ba kafin PD-1 ko PD-L1 inhibitor far. Wannan amincewa yana canza ainihin amfani ga mutanen da ke da ciwon daji na urothelial carcinoma (mUC) waɗanda ke da wasu sauye-sauye a cikin kwayoyin halittar FGFR3 ko FGFR2 kuma an riga an yi musu magani da chemotherapy mai ɗauke da platinum.

Nazarin BLC3001 Cohort 1 ya kalli yadda ta yi aiki sosai. Ya kasance gwajin bazuwar, buɗaɗɗen alamar gwaji tare da mutane 266 waɗanda ke da ciwon daji na urothelial carcinoma (mUC) da wasu maye gurbi na FGFR3. Waɗannan marasa lafiya sun sha maganin 1-2 na baya-bayan nan, wanda ya haɗa da mai hana PD-1 ko PD-L1. An ba da izini ga mahalarta a cikin rabo na 1: 1 don ko dai karɓar erdafitinib ko zaɓin chemotherapy wanda mai binciken ya fi so, wanda zai iya zama docetaxel ko vinflunine. An gudanar da bazuwar bazuwar bisa ga yanki, matsayin aiki, da abin da ya faru na visceral ko ƙashi. A cikin 75% na marasa lafiya a dakin gwaje-gwaje na tsakiya, therascreen FGFR RGQ RT-PCR kit (Qiagen) sun gano maye gurbin FGFR3 a cikin ƙwayar ƙwayar cuta, tare da sauran marasa lafiya waɗanda ke da binciken jeri na gaba na gida sun sami maye gurbin.

Babban ma'aunin inganci shine gaba ɗaya rayuwa (OS). Ƙididdigar mai bincike-ci gaba-kyauta rayuwa (PFS) da ƙimar amsa haƙiƙa (ORR) sun kasance ƙarin ma'aunin sakamako.

An sami ci gaba mai mahimmanci na ƙididdiga a cikin rayuwa gabaɗaya (OS), rayuwa marar ci gaba (PFS), da ƙimar amsa haƙiƙa (ORR) lokacin da aka yi amfani da erdafitinib maimakon chemotherapy. Matsakaicin rayuwa na gaba ɗaya shine watanni 12.1 (95% CI: 10.3, 16.4) ga marasa lafiya da aka bi da su tare da erdafitinib da watanni 7.8 (95% CI: 6.5, 11.1) ga waɗanda suka karɓi chemotherapy. Matsakaicin haɗari (HR) shine 0.64 (95% CI: 0.47, 0.88) tare da p-darajar 0.0050. Rayuwa ba tare da ci gaba ba na tsaka-tsaki shine watanni 5.6 (95% CI: 4.4, 5.7) ga marasa lafiya da aka bi da su tare da erdafitinib da watanni 2.7 (95% CI: 1.8, 3.7) ga wadanda suka karbi chemotherapy. Matsayin haɗari shine 0.58 (95% CI: 0.44, 0.78) tare da p-darajar 0.0002. Matsakaicin ƙimar amsawar haƙiƙa (ORR) shine 35.3% (95% CI: 27.3, 43.9) ga marasa lafiya waɗanda aka bi da su tare da erdafitinib da 8.5% (95% CI: 4.3, 14.6) ga waɗanda suka karɓi chemotherapy (p-darajar <0.001) ).

Mafi yawan halayen halayen haɗari, wanda ke faruwa a cikin fiye da 20% na lokuta, sun haɗa da matakan phosphate masu girma, al'amurran ƙusa, zawo, kumburin baki, ƙananan matakan alkaline phosphatase, rage matakan haemoglobin, haɓaka matakan alanine aminotransferase, haɓaka matakan aspartate aminotransferase, rage yawan matakan aminotransferase. matakan sodium, ƙara yawan matakan creatinine, bushewar baki, raguwar matakan phosphate, yanayin fata da ke shafar tafin hannu da tafin hannu, canjin dandano, gajiya, bushewar fata, maƙarƙashiya, rage cin abinci, ƙara yawan matakan calcium, asarar gashi, bushewar idanu, haɓaka matakan potassium. , da kuma asarar nauyi.

Matsakaicin erdafitinib da aka ba da shawarar shine 8 MG ana ɗaukar baki sau ɗaya a rana, tare da yuwuwar haɓaka zuwa 9 MG sau ɗaya kowace rana bayan kwanaki 14 zuwa 21 dangane da haƙuri, musamman hyperphosphatemia. Ci gaba da jiyya har sai cuta ta ta'azzara ko illar da ba za ta iya jurewa ba.