A ranar 12 ga Fabrairu, 2026, Cibiyar Kimanta Magunguna (CDE) ta Hukumar Kula da Kayayyakin Lafiya ta Ƙasa ta China ta sanar a ranar 4 ga Fabrairu cewa an gabatar da shawarar haɗa ENHERTU® (trastuzumab deruxtecan) cikin Shirin Maganin Breakthrough don amfani da shi azaman maganin taimako ga manya marasa lafiya da ke fama da cutar kansar nono ta farko ta HER2 waɗanda ke da sauran cututtukan da suka shafi mama bayan maganin neoadjuvant anti-HER2. Wannan shawarar ta dogara ne akan bayanai masu ƙarfi daga binciken DESTINY-Breast05 Phase III, wanda aka gabatar a taron ESMO na 2025, wanda ya nuna cewa ENHERTU ta rage haɗarin kamuwa da cutar ba tare da cutar ba (IDFS) ko mutuwa da kashi 53% idan aka kwatanta da T-DM1.
ENHERTU (trastuzumab deruxtecan; fam-trastuzumab deruxtecan-nxki a Amurka kawai) wani kamfani ne na HER2 da aka jagoranta ADC. An tsara shi ta amfani da fasahar DXd ADC ta Daiichi Sankyo, ENHERTU ita ce babbar ADC a cikin fayil ɗin oncology na Daiichi Sankyo kuma shiri mafi ci gaba a cikin dandamalin kimiyya na ADC na AstraZeneca. ENHERTU ya ƙunshi wani ƙwayar cuta ta HER2 monoclonal da aka haɗa zuwa wasu nau'ikan topoisomerase I inhibitor (wani nau'in exatecan, DXd) ta hanyar masu haɗin da za a iya cirewa ta hanyar tetrapeptide.
DESTINY-Breast05 gwaji ne na duniya, mai cibiya da yawa, bazuwar, wanda aka yi wa lakabi da lakabi na mataki na 3, wanda ke kimanta inganci da amincin ENHERTU (5.4 mg/kg) idan aka kwatanta da trastuzumab emtansine (T-DM1) ga marasa lafiya da ke da cutar kansar nono ta farko ta HER2 tare da sauran cututtukan da ke yaɗuwa a cikin nono ko ƙwayoyin lymph bayan maganin neoadjuvant da kuma babban haɗarin sake dawowa. Babban haɗarin sake dawowa an bayyana shi a matsayin gabatar da ciwon daji da ba za a iya yi ba (kafin maganin neoadjuvant) ko ƙwayoyin lymph na axillary masu kyau bayan maganin neoadjuvant.
Muhimman bayanai daga binciken DESTINY-Breast05:
- Rayuwa Ba Tare da Cututtuka Masu Yaɗuwa Ba (IDFS): Adadin IDFS na shekaru uku ya kasance kashi 92.4% a hannun ENHERTU idan aka kwatanta da kashi 83.7% a hannun sarrafawa (T-DM1), wanda ke wakiltar raguwar haɗarin da kashi 53% (HR=0.47).
- Rayuwa Ba Tare da Cututtuka Ba (DFS): Adadin DFS na shekaru uku ya kasance kashi 92.3% a cikin hannun ENHERTU idan aka kwatanta da kashi 83.5% a cikin hannun sarrafawa, wanda hakan ke nuna raguwar haɗarin da kashi 53% (HR=0.47).
- Haɗarin Maimaita Nesa (DRFI): An rage da kashi 51%, tare da ƙimar DRFI na shekaru uku na kashi 93.9% idan aka kwatanta da kashi 86.1%.
- Haɗarin Ciwon Kwakwalwa (BMFI): An rage da kashi 36%, tare da ƙimar BMFI na shekaru uku na kashi 97.6% idan aka kwatanta da kashi 95.8%.
Sashen Duniya na Asibitin Ciwon Daji na Kudancin Birnin Beijing ya sadaukar da kansa ga yi wa marasa lafiya hidima a ƙasashen waje, yana ba da tallafi ga harsuna da yawa, yana ba da kuɗin inshora kai tsaye ga marasa lafiya na ƙasashen waje, yana ba da rakiyar marasa lafiya na musamman, da kuma ayyukan tuntuɓar juna. Ga marasa lafiya da ke fama da cutar kansar nono ta HER2, Sashen Duniya yana ba da ƙungiyar kwararrun likitocin kansa don ƙirƙirar tsare-tsaren magani na musamman.
Tuntuɓi yanzu don kimanta magani:
Layin Sadarwa na Marasa Lafiya na Ƙasashen Duniya: 400-880-3716 (Sabis na awanni 24 na harsuna biyu, Sinanci/Turanci)
Layin WeChat Kai Tsaye: 17801183037
Official Email ①: 100085_010@163.com
Backup Email ②: myimmnet@163.com
Ko kai majiyyaci ne da aka gano yana neman dabarun magance sauran cututtukan bayan maganin neoadjuvant, ko kuma majiyyaci wanda aka yi masa tiyata kuma yana la'akari da wani tsari na musamman na maganin adjuvant, ƙungiyar Ma'aikatar Ƙasashen Duniya za ta iya kammala nazarin bayanan likita na farko da sauri kuma ta ba da shawarwarin magani a rubuce.
Lokacin Saƙo: Fabrairu-12-2026