I te 12 o Pēpuere, 2026, i panuitia e te Center for Drug Evaluation (CDE) o te National Medical Products Administration o Haina i te 4 o Pēpuere kua whakaarohia te whakauru i te ENHERTU® (trastuzumab deruxtecan) ki roto i te Breakthrough Therapy Program hei whakamahi hei rongoā tāpiri i roto i ngā tūroro pakeke he mate pukupuku ū wawe HER2-pai e mau ana i te mate urutā toenga i muri i te rongoā neoadjuvant anti-HER2. I ahu mai tēnei whakatau i ngā raraunga whakamīharo mai i te rangahau DESTINY-Breast05 Phase III, i tukuna ki te 2025 ESMO Congress, i whakaatu i te whakaiti a ENHERTU i te mōrearea o ngā mate urutā kore-mate urutā (IDFS) me te mate rānei mā te 53% ki te whakataurite ki te T-DM1.
Ko te ENHERTU (trastuzumab deruxtecan; fam-trastuzumab deruxtecan-nxki i te US anake) he ADC e arohia ana e te HER2. I hangaia mā te whakamahi i te Hangarau DXd ADC motuhake a Daiichi Sankyo, ko te ENHERTU te ADC matua i roto i te putea oncology a Daiichi Sankyo me te kaupapa tino matatau i roto i te tūāpapa pūtaiao ADC a AstraZeneca. Kei roto i te ENHERTU he paturopi monoclonal HER2 e piri ana ki te maha o ngā kawenga aukati topoisomerase I (he exatecan derivative, DXd) mā roto i ngā hononga tapahi e hangai ana ki te tetrapeptide.
He whakamātautau ā-ao, maha-pokapū, matapōkeretia, tuwhera-tapanga, wāhanga 3 a DESTINY-Breast05 e aromatawai ana i te whai huatanga me te haumaru o ENHERTU (5.4 mg/kg) ki te trastuzumab emtansine (T-DM1) i roto i ngā tūroro he mate pukupuku ū tōmua HER2 pai me te mate urutā toenga i roto i ngā kōpū lymph ū, i ngā kōpū lymph axillary rānei whai muri i te rongoā neoadjuvant me te mōrearea nui o te hokinga mai. Ko te mōrearea nui o te hokinga mai i tautuhia ko te whakaaturanga me te mate pukupuku kāore e taea te mahi (i mua i te rongoā neoadjuvant) me ngā kōpū lymph axillary pai te āhua pathological i muri i te rongoā neoadjuvant.
Ngā raraunga matua mai i te rangahau a DESTINY-Breast05:
- Te Ora Kore Mate Urupare (IDFS): Ko te reiti IDFS mō ngā tau e toru he 92.4% i roto i te peka ENHERTU, i whakaritea ki te 83.7% i roto i te peka whakahaere (T-DM1), he whakahekenga mōrearea 53% (HR=0.47).
- Te Ora Kore-Mate (DFS): Ko te reiti DFS mō ngā tau e toru he 92.3% i roto i te peka ENHERTU, ki te 83.5% i roto i te peka whakahaere, e whakaatu ana hoki i te whakahekenga mōrearea o te 53% (HR=0.47).
- Te Mōrearea Hokinga Mai o te Mate Tawhiti (DRFI): Kua heke iho mā te 51%, me ngā reiti DRFI mō ngā tau e toru he 93.9% ki te 86.1%.
- Te Mōrearea o te Metastasis o te Roro (BMFI): Kua heke iho mā te 36%, me ngā reiti BMI e toru tau o te 97.6% ki te 95.8%.
Ko te Tari Ao o te Hōhipera Matepukupuku o Beijing Southern Suburb e whakatapua ana ki te mahi ki ngā tūroro o tāwāhi, e tuku ana i te tautoko reo maha, te utu tika me te inihua o te ao, te tautoko whaiaro i ngā tūroro, me ngā ratonga whakawhitiwhiti kōrero mamao. Mō ngā tūroro he matepukupuku ū HER2-pai, ka whakaratohia e te Tari Ao he rōpū maha-mātauranga o ngā tohunga matepukupuku matua hei whakawhanake i ngā mahere maimoatanga tāpiri takitahi.
Whakawhitiwhiti kōrero inaianei mō te aromatawai maimoatanga:
Waea Tūroro o te Ao: 400-880-3716 (ratonga reo rua 24-hāora, Hainamana/Ingarihi)
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Ahakoa he tūroro hou koe i tāpaetia ai te mate e rapu ana i ngā rautaki mō ngā mate toenga i muri i te rongoā neoadjuvant, he tūroro rānei kua pokangahia, ā, e whakaaro ana ki tētahi mahere maimoatanga tāpiri kua whakanuia, ka taea e te tīma Tari Ao te whakaoti i tētahi arotake hauora tuatahi i te wā tika, me te tuku tohutohu maimoatanga tuhituhi.
Wā tuku: 12-Pepuere-2026