Jan 2023: Mushonga nadofaragene firadenovec-vncg (Adstiladrin, Ferring Pharmaceuticals) yakatenderwa neFood and Drug Administration kuvarwere vakura vane njodzi, isingasviki-muscle invasive cancer cancer (NMIBC) ine carcinoma in situ (CIS) ine kana isina papillary tumors.
MuChidzidzo CS-003 (NCT02773849), muedzo wakasiyana-siyana, imwe-ruoko rumwechete iyo yaisanganisira varwere ve157 vane NMIBC yepamusoro uye 98 avo vaiva neCIS inogona kuongororwa kuti ipindure, kushanda kwakaongororwa. Kamwe mwedzi mitatu yega yega kusvika kumwedzi gumi nemiviri, huturu husingagoneki, kana kudzoka kwepamusoro-giredhi NMIBC, varwere vakagamuchira nadofaragene firadenovec-vncg 12 mL intravesical instillation (75 x 3 viral particles/mL [vp/mL]). Varwere vaibvumirwa kuramba vachigamuchira nadofaragene firadenovec-vncg mwedzi mitatu yega yega chero bedzi pakanga pasina kudzoka kwepamusoro-soro.
Yakazara mhinduro (CR) chero nguva uye kusimba kwemhinduro yaive yakanyanya efficacy mhedzisiro metrics (DoR). Kuti ukwanise kuve CR, cystoscopy isina kunaka pamwe neTURBT yakakodzera, biopsies, uye weti cytology yaidiwa. Zvishanu zvakasiyana-siyana zvechiropa zvakatorwa zvakangoerekana zvaitika kubva kuvarwere vakanga vachiri muCR mushure megore. Iyo yepakati DoR yaive mwedzi 9.7 (renji: 3, 52+), iyo CR rate yaive 51% (95% CI: 41%, 61%), uye 46% yevarwere vanopindura vakaramba vari muCR kweinenge gore.
Kuwedzera hyperglycemia, instillation site discharge, yakawedzera triglycerides, kuneta, bladder spasm, micturition kukurumidza, kuwedzera creatinine, hematuria, kuderedzwa phosphate, chills, dysuria, uye pyrexia ndiyo yaiwanzoita migumisiro yechirwere (chiitiko 10%), pamwe nekukanganisa kwekuedza ( >15%).
Uchishandisa weti catheter, shandisa 75 mL ye nadofaragene firadenovec-vncg mudundira kamwe chete mwedzi mitatu yega yega pamwero we3 x 1011 vp/mL. Inokurudzirwa kutora anticholinergic semushonga usati waiswa imwe neimwe.
