Ngomhlaka-12 kuNhlolanja 2026, i-Center for Drug Evaluation (CDE) ye-National Medical Products Administration yaseShayina yamemezela ngomhlaka-4 kuNhlolanja ukuthi i-ENHERTU® (trastuzumab deruxtecan) iphakanyisiwe ukuthi ifakwe kuHlelo Lokwelapha Oluphuthumayo ukuze isetshenziswe njengokwelashwa okungeziwe ezigulini ezindala ezinomdlavuza webele we-HER2-positive zakuqala ezinezifo ezihlaselayo ezisele ngemuva kokwelashwa kwe-neoadjuvant anti-HER2. Lesi sinqumo sisekelwe kudatha ethokozisayo evela ocwaningweni lwe-DESTINY-Breast05 Phase III, olwethulwe eNgqungqutheleni ye-ESMO ka-2025, eyabonisa ukuthi i-ENHERTU inciphise ingozi yezehlakalo zokusinda ezingenazifo ezihlaselayo (IDFS) noma ukufa ngo-53% uma kuqhathaniswa ne-T-DM1.
I-ENHERTU (i-trastuzumab deruxtecan; i-fam-trastuzumab deruxtecan-nxki e-US kuphela) iyi-ADC eqondiswe yi-HER2. Yaklanywa kusetshenziswa ubuchwepheshe be-DXd ADC obuyimpahla kaDaiichi Sankyo, i-ENHERTU iyi-ADC ehamba phambili kuphothifoliyo ye-oncology ye-Daiichi Sankyo kanye nohlelo oluthuthuke kakhulu epulatifomu yesayensi ye-ADC ye-AstraZeneca. I-ENHERTU iqukethe i-antibody ye-HER2 monoclonal enamathiselwe eningini le-topoisomerase I inhibitor payloads (i-exatecan derivative, DXd) ngezixhumanisi eziqhekekayo ezisekelwe ku-tetrapeptide.
I-DESTINY-Breast05 iyisilingo sesigaba sesi-3 somhlaba wonke, esinama-multicenter, esingahleliwe, esivulekile, esihlola ukusebenza kahle nokuphepha kwe-ENHERTU (5.4 mg/kg) uma kuqhathaniswa ne-trastuzumab emtansine (T-DM1) ezigulini ezinomdlavuza webele wokuqala one-HER2 positive onesifo esisele esihlaselayo kuma-lymph node ebele noma e-axillary ngemuva kokwelashwa kwe-neoadjuvant kanye nengozi ephezulu yokuphinda sivele. Ingozi ephezulu yokuphinda sivele ichazwe njengokubonakaliswa komdlavuza ongasebenzi (ngaphambi kokwelashwa kwe-neoadjuvant) noma ama-lymph node e-axillary positive ngemuva kokwelashwa kwe-neoadjuvant.
Idatha ebalulekile evela ocwaningweni lwe-DESTINY-Breast05:
- Ukusinda Okungenayo Izifo Ezihlaselayo (i-IDFS): Izinga le-IDFS leminyaka emithathu lalingu-92.4% engalweni ye-ENHERTU uma kuqhathaniswa no-83.7% engalweni yokulawula (i-T-DM1), okumele ukwehla kwengozi okungu-53% (HR=0.47).
- Ukusinda Okungenazifo (i-DFS): Izinga le-DFS leminyaka emithathu lalingu-92.3% engalweni ye-ENHERTU uma kuqhathaniswa no-83.5% engalweni yokulawula, okubonisa nokunciphisa ubungozi okungu-53% (HR=0.47).
- Ingozi Yokuphindeka Okude (i-DRFI): Yehliswe ngo-51%, ngamanani e-DRFI eminyaka emithathu angu-93.9% uma kuqhathaniswa no-86.1%.
- Ingozi Yokusabalala Kobuchopho (i-BMFI): Yehliswe ngo-36%, ngamazinga e-BMFI eminyaka emithathu angu-97.6% uma kuqhathaniswa no-95.8%.
UMnyango Wezangaphandle Wesibhedlela Somdlavuza saseBeijing Southern Suburb uzinikele ekukhonzeni iziguli zakwamanye amazwe, unikeza ukwesekwa kwezilimi eziningi, ukukhokhisa ngqo ngomshuwalense wamazwe ngamazwe, ukuhambisana neziguli ngokwezifiso, kanye nezinsizakalo zokubonisana ngocingo. Ezigulini ezinomdlavuza webele one-HER2-positive, uMnyango Wezangaphandle uhlinzeka ngethimba lodokotela abaphezulu abanolwazi oluhlukahlukene ukuthuthukisa izinhlelo zokwelapha ezisizayo ezizimele.
Bheka manje ukuze uthole ukuhlolwa kokwelashwa:
Ucingo Lokuxhumana Neziguli Lwamazwe Ngamazwe: 400-880-3716 (isevisi yamahora angama-24 yezilimi ezimbili, isiShayina/isiNgisi)
Ulayini Oqondile we-WeChat: 17801183037
Official Email ①: 100085_010@163.com
Backup Email ②: myimmnet@163.com
Kungakhathaliseki ukuthi uyisiguli esisanda kutholakala ukuthi sifuna amasu okwelapha isifo esisele ngemuva kokwelashwa kwe-neoadjuvant, noma isiguli esiye sahlinzwa futhi sicabangela uhlelo lokwelashwa oluthuthukisiwe lwe-adjuvant, ithimba loMnyango Wezamazwe Ngamazwe lingaqedela ukubuyekezwa kwamarekhodi ezokwelapha kwasekuqaleni ngokushesha futhi linikeze izincomo zokwelashwa ezibhaliwe.
Isikhathi sokuthunyelwe: Feb-12-2026