Musi wa12 Kukadzi, 2026, Center for Drug Evaluation (CDE) yeChina's National Medical Products Administration yakazivisa musi wa4 Kukadzi kuti ENHERTU® (trastuzumab deruxtecan) yakakurudzirwa kuti ibatanidzwe muBreakthrough Therapy Program kuti ishandiswe semushonga wekubatsira varwere vakuru vane kenza yemazamu yekutanga yeHER2-positive vane chirwere chekugara mushure mekurapwa neoadjuvant anti-HER2. Sarudzo iyi yakavakirwa padata rinogutsa kubva kuDESTINY-Breast05 Phase III study, yakapihwa pa2025 ESMO Congress, iyo yakaratidza kuti ENHERTU yakaderedza njodzi yezviitiko zvekugara pasina chirwere (IDFS) kana kufa ne53% zvichienzaniswa neT-DM1.
ENHERTU (trastuzumab deruxtecan; fam-trastuzumab deruxtecan-nxki muUS chete) iADC inotungamirwa neHER2. Yakagadzirwa uchishandisa Daiichi Sankyo's proprietary DXd ADC Technology, ENHERTU ndiyo ADC inotungamira mu oncology portfolio yeDaiichi Sankyo uye chirongwa chepamusoro-soro muAstraZeneca's ADC scientific platform. ENHERTU ine HER2 monoclonal antibody yakabatana nenhamba ye topoisomerase I inhibitor payloads (exatecan derivative, DXd) kuburikidza ne tetrapeptide-based cleavable linkers.
DESTINY-Breast05 iongororo yepasi rose, ine nzvimbo dzakawanda, isina kurongeka, yakavhurika, yechikamu chechitatu ichiongorora kushanda uye kuchengetedzeka kweENHERTU (5.4 mg/kg) zvichienzaniswa netrastuzumab emtansine (T-DM1) muvarwere vane HER2 positive early cancer vane chirwere chinosara muzamu kana axillary lymph nodes mushure mekurapwa neoadjuvant uye njodzi huru yekudzoka. Njodzi huru yekudzoka yakatsanangurwa sekuratidzwa kwekenza isingarapike (isati yatanga kurapwa neoadjuvant) kana axillary lymph nodes mushure mekurapwa neoadjuvant.
Ruzivo rwakakosha kubva muchidzidzo cheDESTINY-Breast05:
- Kupona Kusina Zvirwere Zvinopinda Mumuviri (IDFS): Mwero weIDFS wemakore matatu waive 92.4% muruoko rweENHERTU uchienzaniswa ne83.7% muruoko rwekudzora (T-DM1), zvichireva kudzikira kwengozi ne53% (HR=0.47).
- Kupona Pasina Zvirwere (DFS): Mwero weDFS wemakore matatu waive 92.3% muchikamu cheENHERTU uchienzaniswa ne83.5% muchikamu chekutonga, zvichiratidzawo kudzikiswa kwengozi ne53% (HR=0.47).
- Njodzi yeKudzoka Kwenguva Iri Kure (DRFI): Yakaderedzwa ne51%, nenhamba dzeDRFI dzemakore matatu dze93.9% zvichienzaniswa ne86.1%.
- Njodzi yeBrain Metastasis (BMFI): Yaderedzwa ne36%, nehuwandu hweBMFI hwemakore matatu hwe97.6% zvichienzaniswa ne95.8%.
Dhipatimendi reInternational Department reBeijing Southern Suburb Cancer Hospital rakatsaurirwa kushandira varwere vari kunze kwenyika, kupa rutsigiro rwemitauro yakawanda, kubhadharisa zvakananga neinishuwarenzi yepasi rose, kuperekedza varwere vakasiyana-siyana, uye masevhisi ekutaurirana nefoni. Kune varwere vane kenza yemazamu yeHER2-positive, Dhipatimendi reInternational rinopa timu yevanachiremba vakuru vekenza vane hunyanzvi hwakasiyana-siyana kuti vagadzire zvirongwa zvekurapa zve adjuvant zvakasiyana-siyana.
Bvunza izvozvi kuti uwane kuongororwa kwekurapwa:
Nhare yeInternational Patient Hotline: 400-880-3716 (rubatsiro rwemaawa makumi maviri nemana rwekutaura mitauro miviri, chiChinese/Chirungu)
Mutsetse weWeChat: 17801183037
Official Email ①: 100085_010@163.com
Backup Email ②: myimmnet@163.com
Ungave uri murwere achangobva kuongororwa chirwere ichi ari kutsvaga nzira dzekurapa chirwere chisingaperi mushure mekurapwa neoadjuvant, kana murwere akavhiyiwa uye ari kufunga nezvechirongwa chekurapa cheadjuvant chakawedzerwa, timu yeInternational Department inogona kupedzisa ongororo yekutanga yezvinyorwa zvekurapa nekukurumidza uye kupa mazano ekurapa akanyorwa.
Nguva yekutumira: Kukadzi-12-2026