Erdafitinib inotenderwa neUSFDA kune yemuno advanced kana metastatic urothelial carcinoma

Erdafitinib (Balversa, Janssen Biotech) yakatenderwa neChikafu neDrug Administration muna Ndira 19, 2024, kuvarwere vakuru vane FGFR3 genetic shanduko vane munharaunda yepamusoro kana metastatic urothelial carcinoma (mUC). Varwere vane chirwere chavo chakawedzera mushure mekugamuchira kamwe chete yekutanga systemic therapy vanokodzera kuwana iyi mvumo, sekureva kweFDA-yakatenderwa shamwari yekuongorora bvunzo. Erdafitinib haikurudzirwe kurapa varwere vanokodzera uye vasina kumboita PD-1 kana PD-L1 inhibitor therapy. Mvumo iyi inoshandura kushandiswa kwepakutanga kwevanhu vane metastatic urothelial carcinoma (mUC) vane dzimwe shanduko muFGFR3 kana FGFR2 majini uye vakatorapwa neplatinum-containing chemotherapy.

Kudzidza BLC3001 Cohort 1 yakatarisa kuti yakashanda sei. Yakanga iri muyedzo wakasarudzika, wakavhurika-label nevanhu 266 vaive nemetastatic urothelial carcinoma (mUC) uye kumwe kuchinja kweFGFR3. Varwere ava vaive vaita 1-2 yapfuura systemic therapies, iyo yaisanganisira PD-1 kana PD-L1 inhibitor. Vatori vechikamu vakapihwa zvisina tsarukano muchiyero che1: 1 kuti vagamuchire erdafitinib kana sarudzo yemuongorori yakasarudzika yechemotherapy, inogona kunge iri docetaxel kana vinflunine. Stratified randomization yakaitwa zvichienderana nenzvimbo, chimiro chekushanda, uye kuitika kwe visceral kana bone metastases. Muchikamu che75% chevarwere vari murabhoritari yepakati, therascreen FGFR RGQ RT-PCR kit (Qiagen) yakaona kuchinja kweFGFR3 mumatumbu, nevarwere vakasara vaine zvidzidzo zvekutevedzana kwechizvarwa chinotevera vanowana shanduko.

Chiyero chekutanga chekushanda kwaive kupona kwese (OS). Muongorori-akaongororwa kufambira mberi-kusina kupona (PFS) uye chinangwa chekupindura mwero (ORR) aive ekuwedzera mhedzisiro metrics.

Paive nekuvandudzwa kwakakosha mukurarama kwese (OS), kufambira mberi-kusina kupona (PFS), uye mwero wekupindura chinangwa (ORR) pakashandiswa erdafitinib pachinzvimbo chechemotherapy. Kupona kwepakati kwepakati kwaiva 12.1 mwedzi (95% CI: 10.3, 16.4) kune varwere vanobatwa neerdafitinib uye 7.8 mwedzi (95% CI: 6.5, 11.1) kune avo vakagamuchira chemotherapy. The hazard ratio (HR) yaiva 0.64 (95% CI: 0.47, 0.88) ine p-value ye0.0050. Kurarama kwepakati-pasina kusununguka kwaiva mwedzi 5.6 (95% CI: 4.4, 5.7) kune varwere vanobatwa neerdafitinib uye mwedzi 2.7 (95% CI: 1.8, 3.7) kune avo vakagamuchira chemotherapy. Huwandu hwengozi hwaive 0.58 (95% CI: 0.44, 0.78) ine p-value ye0.0002. Iyo yakasimbiswa chinangwa chekupindura chiyero (ORR) yaive 35.3% (95% CI: 27.3, 43.9) kune varwere vakabatwa neerdafitinib uye 8.5% (95% CI: 4.3, 14.6) kune avo vakagamuchira chemotherapy (p-kukosha <0.001 )

Izvo zvinowanzoitika zvakashata zvinowanzoitika mune zvinopfuura 20% zvezviitiko, zvaisanganisira yakakwirira phosphate mazinga, nyaya dzembambo, manyoka, kuzvimba kwemuromo, yakakwira alkaline phosphatase mazinga, yakaderedzwa hemoglobin mazinga, yakakwira alanine aminotransferase mazinga, yakakwira aspartate aminotransferase mazinga, yakaderedzwa. sodium mazinga, kuwedzera creatinine mazinga, muromo wakaoma, kuderedzwa phosphate mazinga, mamiriro eganda anobata zvanza nezvigadziko, akachinja pfungwa yekuravira, kuneta, yakaoma ganda, kuvimbiswa, kuderera kwechido, kuwedzera calcium mazinga, kurasikirwa kwebvudzi, kuoma kwemaziso, yakakwirira potassium mazinga. , uye kuderedza uremu.

Iyo yakakurudzirwa erdafitinib dosage ndeye 8 mg inotorwa nemuromo kamwe chete pazuva, ine inogona kuwedzera ku9 mg kamwe pazuva mushure me14 kune 21 mazuva zvichienderana nekushivirira, kunyanya hyperphosphatemia. Ramba uchirapa kusvikira chirwere chawedzera kana kuti migumisiro isingashiviriri.