Ngomhlaka-10 Juni, i-Center for Drug Evaluation (CDE) ye-National Medical Products Administration (NMPA) yamemezela ukuthi i-Trastuzumab Deruxtecan (T-DXd, DS-8201a) ihlongozwa ukuthi inikezwe isibuyekezo esibalulekile sokwelashwa kweziguli ezindala ezine-HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma ethuthukisiwe noma esakazeke endaweni ethile eziye zathola ukwelashwa okukodwa kwangaphambilini.
Esivivinyweni se-Phase II se-DESTINY-Gastric01, i-DS-8201 ithuthukise kakhulu amazinga okuphendula kanye nokusinda okuphelele ezigulini ezine-HER2-positive gastric adenocarcinoma (GC) noma i-gastroesophageal junction (GEJ) adenocarcinoma. Lesi sivivinyo sabhalisa iziguli ezingu-125 ezelashwe nge-DS-8201, sibonisa izinga lokuphendula eliqondile (ORR) elingu-51%, ubude besikhathi esimaphakathi (DOR) bezinyanga ezingu-11.3, kanye nezinga lokulawula izifo (DCR) elingu-86%.
Ucwaningo lweSigaba III se-DESTINY-Gastric04 luhlole ukusebenza kahle kanye nokuphepha kwe-Trastuzumab Deruxtecan (6.4 mg/kg) uma kuqhathaniswa ne-ramucirumab kanye ne-paclitaxel njengokwelashwa komugqa wesibili kweziguli ezine-HER2-positive engasuswa kanye/noma i-metastatic gastric noma i-GEJ adenocarcinoma. Imiphumela ibonise ukuthi, kusukela ngo-Okthoba 24, 2024, iqembu le-trastuzumab deruxtecan libonise ukusinda okuphelele okude kakhulu (OS) (izinyanga ezingu-14.7 uma kuqhathaniswa nezinyanga ezingu-11.4, i-HR=0.70, i-P=0.0044) kanye nokusinda okungenazo inqubekela phambili (PFS) (izinyanga ezingu-6.7 uma kuqhathaniswa nezinyanga ezingu-5.6). I-ORR nayo yayiphezulu (44.3% uma kuqhathaniswa no-29.1%), njengoba kwakunjalo ne-DCR (91.9% uma kuqhathaniswa no-75.9%).
I-Trastuzumab deruxtecan (eyayikade i-DS-8201), i-antibody-drug conjugate equkethe i-antibody ye-anti-HER2 monoclonal eyenziwe umuntu exhunywe ku-topoisomerase I inhibitor payload nge-tetrapeptide-based cleavable linker, ivunyelwe ukwelashwa kweziguli ezinomdlavuza webele we-HER2-positive. Ngokungafani nezinye izindlela zokwelapha eziningi ezivunyiwe ze-HER2, i-trastuzumab deruxtecan ingaphinde ihlose ngempumelelo amaseli esimila aveza amazinga aphansi e-HER2 futhi ingaletha umthwalo wayo onamandla we-cytotoxic (isilinganiso semithi-kuya-antibody, 8:1) ngomphumela we-stander kumaseli esimila aseduze aveza i-HER2 ngendlela ehlukile.
Njengamanje, kusenezivivinyo eziningi zemitholampilo zobuchwepheshe obusha bokulwa nomdlavuza eShayina ezifuna iziguli. Ukubonisana ngemithi emisha kanye nobuchwepheshe, ungaxhumana noMnyango Wezizwe Ngezizwe Wesibhedlela iBeijing South Region Oncology.
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Isikhathi sokuthunyelwe: Juni-19-2025