Sabon Magani na Ciwon Urorin Jiki da Marasa lafiya MIBC

Sabuwar binciken magani (IND) ta sami amincewar FDA ta Amurka a watan Yuni da Cibiyar Nazarin Magunguna (CDE) na Hukumar Kula da Kayayyakin Magunguna ta kasar Sin a watan Oktoban bara.

Wannan alama ce mai buɗewa, bincike na asibiti da yawa na Mataki na I / II tare da maƙasudai masu zuwa: don kimanta amincin marasa lafiya na MIBC; don ƙayyade ƙimar da aka ba da shawarar Mataki na 2 (RP2D), da kuma tantance inganci azaman maganin neoadjuvant don MIBC.

"APL-1202 a hade tare da tislelizumab a matsayin maganin neoadjuvant yana da damar zama mafi kyawun magani ga marasa lafiya na MIBC, mun yi farin ciki da cewa mai haƙuri na farko ya gudanar da shi a Amurka," in ji Dokta Xue Yong, MD, PhD, Babban Jami'in Lafiya. Ma'aikatar Asiya. "Mun sami nasarar ci gaba da gwajin a tsakanin cutar ta COVID-19 wanda ke nuna ba wai kawai aiwatar da aiwatar da aikin kungiyar mu ba, har ma da jajircewarmu na inganta lafiyar dan adam."

APL-1202 shine mai hana MetAP2 mai jujjuyawa ta baka tare da anti-angiogenic, ayyukan anti-tumo kuma yana iya canza yanayin ƙwayoyin rigakafi na ƙari. A halin yanzu yana cikin Phase III / gwaji na asibiti a kasar Sin, ko dai a matsayin wakili guda ɗaya azaman jiyya ta farko ga marasa lafiya da ke da matsakaicin haɗarin cutar kansa mara tsoka (NMIBC), ko a hade tare da chemotherapy azaman jiyya na layi na biyu. marasa lafiya tare da matsakaici da babban haɗari chemo-refractory NMIBC. Tislelizumab shine ɗan adam IgG4 anti-PD-1 monoclonal antibody wanda aka tsara musamman don rage ɗaure zuwa FcγR akan macrophages. Hukumar Kula da Kayayyakin Magunguna ta kasar Sin (NMPA) ta amince da tislelizumab a cikin alamomi biyar, ciki har da cikakken amincewa don kula da marasa lafiya da ke fama da ciwon daji na huhu mara karamin kwayar cuta (NSCLC) a hade tare da chemotherapy da kuma kula da marasa lafiya a layi na farko. tare da ci-gaba mara squamous NSCLC a hade tare da chemotherapy. NMPA ta kuma ba da izinin sharadi don kula da marasa lafiya tare da lymphoma na Hodgkin na gargajiya (cHL) waɗanda suka karɓi aƙalla magunguna biyu na farko, don kula da marasa lafiya da ke da ci gaba a cikin gida ko ƙwayar cutar urothelial carcinoma (UC) tare da babban magana na PD-L1 wanda cutar ta ci gaba a lokacin. ko biye da chemotherapy mai ɗauke da platinum ko a cikin watanni 12 na neoadjuvant ko adjuvant magani tare da chemotherapy mai ɗauke da platinum, da kuma kula da marasa lafiya masu ciwon hanta (HCC) waɗanda suka sami aƙalla tsarin tsarin tsarin. Cikakken yarda ga waɗannan alamomin ya dogara ne akan sakamako daga ci gaba da bazuwar gwajin gwaji na asibiti.