ENHERTU Yapereka Udindo Wabwino Kwambiri ku China pa Khansa ya M'mawere Yoopsa Kwambiri ya HER2+ - Deta Yothandizira Ikuwonetsa Ubwino wa 53% wa IDFS

Pa February 12, 2026, Center for Drug Evaluation (CDE) ya China's National Medical Products Administration idalengeza pa February 4 kuti ENHERTU® (trastuzumab deruxtecan) yaperekedwa kuti iphatikizidwe mu Breakthrough Therapy Program kuti igwiritsidwe ntchito ngati chithandizo chothandizira odwala akuluakulu omwe ali ndi khansa ya m'mawere yoyambirira ya HER2 omwe ali ndi matenda otsala olowa pambuyo pa chithandizo cha neoadjuvant anti-HER2. Chisankhochi chachokera pa deta yokhutiritsa kuchokera ku kafukufuku wa DESTINY-Breast05 Phase III, womwe udaperekedwa ku 2025 ESMO Congress, womwe udawonetsa kuti ENHERTU idachepetsa chiopsezo cha zochitika zopulumuka matenda osalowa (IDFS) kapena imfa ndi 53% poyerekeza ndi T-DM1.

ENHERTU (trastuzumab deruxtecan; fam-trastuzumab deruxtecan-nxki ku US kokha) ndi ADC yotsogozedwa ndi HER2. Yopangidwa pogwiritsa ntchito ukadaulo wa Daiichi Sankyo wa DXd ADC, ENHERTU ndiye ADC yotsogola mu pulogalamu ya oncology ya Daiichi Sankyo komanso pulogalamu yapamwamba kwambiri mu nsanja yasayansi ya ADC ya AstraZeneca. ENHERTU ili ndi antibody ya monoclonal ya HER2 yolumikizidwa ku ma payload angapo a topoisomerase I inhibitor (yochokera ku exatecan, DXd) kudzera mu ma linker otseguka okhala ndi tetrapeptide.

DESTINY-Breast05 ndi mayeso apadziko lonse lapansi, okhala ndi malo ambiri, osasankhidwa mwachisawawa, otseguka, gawo lachitatu loyesa mphamvu ndi chitetezo cha ENHERTU (5.4 mg/kg) poyerekeza ndi trastuzumab emtansine (T-DM1) mwa odwala omwe ali ndi khansa ya m'mawere yoyambirira ya HER2 yokhala ndi matenda otsala m'maselo a m'mawere kapena a m'khwapa pambuyo pa chithandizo cha neoadjuvant komanso chiopsezo chachikulu chobwereranso. Chiwopsezo chachikulu chobwereranso chinatanthauzidwa ngati kuwonetsedwa ndi khansa yosachiritsika (asanayambe chithandizo cha neoadjuvant) kapena ma lymph node a m'khwapa omwe ali ndi matenda pambuyo pa chithandizo cha neoadjuvant.

Deta yofunika kwambiri kuchokera ku kafukufuku wa DESTINY-Breast05:
- Kupulumuka Kopanda Matenda Olowa M'thupi (IDFS): Chiwerengero cha IDFS cha zaka zitatu chinali 92.4% mu mkono wa ENHERTU poyerekeza ndi 83.7% mu mkono wolamulira (T-DM1), zomwe zikutanthauza kuchepa kwa chiopsezo ndi 53% (HR=0.47).
- Kupulumuka Kopanda Matenda (DFS): Chiŵerengero cha zaka zitatu cha DFS chinali 92.3% mu mkono wa ENHERTU poyerekeza ndi 83.5% mu mkono wolamulira, zomwe zikuwonetsanso kuchepetsa chiopsezo cha 53% (HR=0.47).
- Chiwopsezo Chobwerezabwereza Chakutali (DRFI): Chachepetsedwa ndi 51%, ndi chiwopsezo cha DRFI cha zaka zitatu cha 93.9% poyerekeza ndi 86.1%.
- Chiwopsezo cha Metastasis mu Ubongo (BMFI): Chachepetsedwa ndi 36%, ndi chiŵerengero cha BMFI cha zaka zitatu cha 97.6% poyerekeza ndi 95.8%.

Dipatimenti Yapadziko Lonse ya Chipatala cha Khansa cha Beijing Southern Suburb yadzipereka kutumikira odwala akunja, kupereka chithandizo cha zilankhulo zosiyanasiyana, kulipira mwachindunji ndi inshuwaransi yapadziko lonse, kutsata odwala payekha, komanso ntchito zolumikizirana pafoni. Kwa odwala omwe ali ndi khansa ya m'mawere ya HER2, Dipatimenti Yapadziko Lonse imapereka gulu la akatswiri akuluakulu a khansa kuti apange mapulani othandizira payekha.

Funsani tsopano kuti muone ngati chithandizo chili bwino:
Nambala Yothandizira Odwala Padziko Lonse: 400-880-3716 (utumiki wa maola 24 wolankhula zilankhulo ziwiri, Chitchaina/Chingerezi)
Mzere Wolunjika wa WeChat: 17801183037
Official Email ①: 100085_010@163.com
Backup Email ②: myimmnet@163.com

Kaya ndinu wodwala amene wangopezeka kumene amene akufuna njira zothetsera matenda otsala pambuyo pa chithandizo cha neoadjuvant, kapena wodwala amene wachitidwa opaleshoni ndipo akuganiza zokonza dongosolo la chithandizo cha adjuvant, gulu la International Department likhoza kumaliza kafukufuku woyamba wa zolemba zachipatala mwamsanga ndikupereka malangizo olembedwa okhudza chithandizo.