An Ba da Shawarwari Kan Musamman Kan Maganin Ciwon Ciki Na HER2-Positive A China

A ranar 10 ga Yuni, Cibiyar Kimanta Magunguna (CDE) ta Hukumar Kula da Kayayyakin Lafiya ta Kasa (NMPA) ta sanar da cewa an gabatar da shawarar a ba Trastuzumab Deruxtecan (T-DXd, DS-8201a) fifiko wajen kula da marasa lafiya manya da ke fama da cutar HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma a gida ko kuma wadanda suka sami magani daya a baya.

A cikin gwajin Phase II DESTINY-Gastric01, DS-8201 ya inganta yawan amsawa da kuma rayuwa gabaɗaya a cikin marasa lafiya da ke fama da cutar HER2-positive gastric adenocarcinoma (GC) ko gastroesophageal junction (GEJ) adenocarcinoma. Gwajin ya yi wa marasa lafiya 125 da aka yi wa magani da DS-8201, wanda ya nuna ƙimar amsawa ta zahiri (ORR) na 51%, matsakaicin tsawon lokacin amsawa (DOR) na watanni 11.3, da kuma ƙimar sarrafa cututtuka (DCR) na 86%.

Binciken Mataki na III na DESTINY-Gastric04 ya kimanta inganci da amincin Trastuzumab Deruxtecan (6.4 mg/kg) idan aka kwatanta da ramucirumab da paclitaxel a matsayin magani na biyu ga marasa lafiya da ke fama da cutar HER2-positive wanda ba a iya cirewa ko/ko metastatic gastritis ko GEJ adenocarcinoma. Sakamakon ya nuna cewa, ya zuwa ranar 24 ga Oktoba, 2024, ƙungiyar trastuzumab deruxtecan ta nuna tsawon rai (OS) (watanni 14.7 idan aka kwatanta da watanni 11.4, HR=0.70, P=0.0044) da kuma rayuwa ba tare da ci gaba ba (PFS) (watanni 6.7 idan aka kwatanta da watanni 5.6). ORR kuma ya fi girma (44.3% idan aka kwatanta da 29.1%), kamar yadda DCR (91.9% idan aka kwatanta da 75.9%).

An amince da Trastuzumab deruxtecan (wanda a da ake kira DS-8201), wani maganin rigakafi da magani wanda ya ƙunshi wani maganin rigakafi na HER2 monoclonal wanda aka haɗa shi da topoisomerase I inhibitor ta hanyar haɗin tetrapeptide mai iya cirewa, don maganin marasa lafiya da ke fama da cutar kansar nono ta HER2 mai kama da ta metastatic. Ba kamar sauran magungunan da aka amince da su na HER2 ba, trastuzumab deruxtecan kuma yana iya kai hari ga ƙwayoyin ciwon daji waɗanda ke nuna ƙarancin matakan HER2 kuma yana iya isar da ƙarfinsa na cytotoxic load (rabo daga magani zuwa antibody, 8:1) ta hanyar tasirin da ke bi ta hanyar gani zuwa ƙwayoyin ciwon daji maƙwabta waɗanda ke nuna HER2 daban-daban.

A halin yanzu, har yanzu akwai gwaje-gwaje da yawa na asibiti na sabbin fasahohin yaƙi da cutar kansa a China waɗanda ke neman marasa lafiya. Tuntuɓi kan sabbin magunguna da fasahohi, zaku iya tuntuɓar Sashen Ƙasa da Ƙasa na Asibitin Oncology na Yankin Kudu na Beijing.

Lambar Waya: 4008803716

Email：myimmnet@163.com