Na Febụwarị 12, 2026, Center for Drug Evaluation (CDE) nke National Medical Products Administration nke China kwupụtara na Febụwarị 4 na a tụrụ aro ka etinye ENHERTU® (trastuzumab deruxtecan) na Mmemme Ọgwụgwọ Breakthrough maka iji dị ka ọgwụgwọ mgbakwunye na ndị okenye nwere ọrịa kansa ara HER2 nke nwere ọrịa mbụ nke na-ebute ọrịa na-efe efe mgbe ọgwụgwọ neoadjuvant anti-HER2 gasịrị. Mkpebi a dabere na data siri ike sitere na ọmụmụ DESTINY-Breast05 Phase III, nke ewepụtara na 2025 ESMO Congress, nke gosipụtara na ENHERTU belatara ihe egwu nke ihe omume ndụ na-enweghị ọrịa (IDFS) ma ọ bụ ọnwụ site na 53% ma e jiri ya tụnyere T-DM1.
ENHERTU (trastuzumab deruxtecan; fam-trastuzumab deruxtecan-nxki na US naanị) bụ ADC nke HER2 duziri. E ji teknụzụ DXd ADC nke Daiichi Sankyo mepụtara ya, ENHERTU bụ ADC mbụ na ngalaba oncology nke Daiichi Sankyo na mmemme kachasị elu na ikpo okwu sayensị ADC nke AstraZeneca. ENHERTU nwere ọgwụ mgbochi HER2 monoclonal nke ejikọtara na ọtụtụ ibu ọrụ topoisomerase I inhibitor (ihe exatecan derivative, DXd) site na njikọ ndị a na-apụghị ịgbagha agbagha dabere na tetrapeptide.
DESTINY-Breast05 bụ nnwale zuru ụwa ọnụ, nke nwere ọtụtụ etiti, nke a na-agbanweghi agbanwe, nke e meghere emepe, nke na-enyocha irè na nchekwa nke ENHERTU (5.4 mg/kg) megide trastuzumab emtansine (T-DM1) n'ime ndị ọrịa nwere ọrịa kansa ara HER2 dị n'oge mbụ nwere ọrịa na-awakpo ara ma ọ bụ lymph nodes mgbe ọgwụgwọ neoadjuvant gasịrị na nnukwu ihe egwu nke nlọghachi azụ. A kọwara nnukwu ihe egwu nke nlọghachi azụ dị ka ngosipụta nke kansa a na-apụghị ịgwọ (tupu ọgwụgwọ neoadjuvant) ma ọ bụ lymph nodes axillary dị mma na-esochi ọgwụgwọ neoadjuvant.
Isi ihe dị mkpa sitere na ọmụmụ DESTINY-Breast05:
- Nlanarị Na-enweghị Ọrịa Na-awakpo (IDFS): Ọnụego IDFS nke afọ atọ bụ 92.4% na ogwe aka ENHERTU ma e jiri ya tụnyere 83.7% na ogwe aka njikwa (T-DM1), nke na-anọchite anya mbelata 53% na ihe egwu (HR=0.47).
- Nlanarị Na-enweghị Ọrịa (DFS): Ọnụego DFS nke afọ atọ bụ 92.3% na ogwe aka ENHERTU ma e jiri ya tụnyere 83.5% na ogwe aka njikwa, nke na-egosipụtakwa mbelata ihe egwu nke 53% (HR=0.47).
- Ihe Ize Ndụ Nleghachi Anya (DRFI): E belatara site na 51%, yana ọnụego DRFI nke afọ atọ nke 93.9% megide 86.1%.
- Ihe Ize Ndụ nke Metastasis nke Ụbụrụ (BMFI): Ebelatala site na 36%, yana ọnụego BMFI nke afọ atọ nke 97.6% megide 95.8%.
Ngalaba Mba Nile nke Ụlọ Ọgwụ Ọrịa Kansa nke Beijing Southern Suburb raara onwe ya nye ijere ndị ọrịa si mba ofesi ozi, na-enye nkwado asụsụ dị iche iche, na-akwụ ụgwọ ozugbo site na mkpuchi mba ụwa, na-eso ndị ọrịa eme ihe nkeonwe, na ọrụ ndụmọdụ ekwentị. Maka ndị ọrịa nwere kansa ara HER2-positive, Ngalaba Mba Nile na-enye otu ndị ọkachamara n'ọrịa kansa dị iche iche iji mepụta atụmatụ ọgwụgwọ adjuvant nkeonwe.
Gaa ugbu a maka nyocha ọgwụgwọ:
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Ma ị bụ onye ọrịa a chọpụtara ọhụrụ nke na-achọ usoro maka ọrịa fọdụrụ mgbe ọgwụgwọ neoadjuvant gasịrị, ma ọ bụ onye ọrịa a wachara ahụ ma na-atụle atụmatụ ọgwụgwọ adjuvant ka njọ, ndị otu Ngalaba Mba Nile nwere ike mezue nyocha ndekọ ahụike mbụ ozugbo ma nye ndụmọdụ ederede maka ọgwụgwọ.
Oge ozi: Febụwarị-12-2026