A ranar 17 ga Yuli, Cibiyar Kimanta Magunguna (CDE) ta Hukumar Kayayyakin Lafiya ta Ƙasa (NMPA) ta sanar da cewa NMPA ta amince da aikace-aikacen tallatawa na Trastuzumab Deruxtecan (Enhertu®) don maganin ciwon daji na ciki na mataki na biyu a hukumance. An yi nufin wannan aikace-aikacen ne don maganin manya da ke fama da ciwon daji na ciki ko na gastroesophageal a yanayin layi na biyu.
ENHERTU (trastuzumab deruxtecan; fam-trastuzumab deruxtecan-nxki a Amurka kawai) wani kamfani ne na HER2 da aka jagoranta ADC. An tsara shi ta amfani da fasahar DXd ADC ta Daiichi Sankyo, ENHERTU ita ce babbar ADC a cikin fayil ɗin oncology na Daiichi Sankyo kuma shiri mafi ci gaba a cikin dandamalin kimiyya na ADC na AstraZeneca. ENHERTU ya ƙunshi wani ƙwayar cuta ta HER2 monoclonal da aka haɗa zuwa wasu nau'ikan topoisomerase I inhibitor (wani nau'in exatecan, DXd) ta hanyar masu haɗin da za a iya cirewa ta hanyar tetrapeptide.
A halin yanzu, har yanzu akwai gwaje-gwaje da yawa na asibiti na sabbin fasahohin yaƙi da cutar kansa a China waɗanda ke neman marasa lafiya. Tuntuɓi kan sabbin magunguna da fasahohi, zaku iya tuntuɓar Sashen Ƙasa da Ƙasa na Asibitin Oncology na Yankin Kudu na Beijing.
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Wannan aikace-aikacen yin rijista ya dogara ne akan mahimman bayanai da mahimman sakamako na binciken DESTINY-Gstric04 (wanda aka gabatar a taron ASCO na Ƙungiyar Nazarin Cututtukan Cututtukan Amurka a 2025).
DESTINY-Gastric04 (NCT04704934), wani bincike na duniya, wanda aka tsara, mai cibiyoyi da yawa, mai buɗewa, mataki na 3 wanda ke kimanta inganci da amincin T DXd vs RAM + PTX a cikin maki tare da HER2+ wanda ba za a iya cirewa ba/wanda ba a iya gano shi ba/GC/GEJA a cikin wannan saitin layi na biyu.
Hanyoyi:
Bayan an tabbatar da yanayin HER2+ (IHC 3+ ko IHC 2+/ISH+) ta hanyar biopsy, an yi amfani da maki 1:1 zuwa T-DXd 6.4 mg/kg ko RAM + PTX. Babban maƙasudin ƙarshe shine cikakken rayuwa (OS). An kwatanta tsarin aiki tsakanin hannayen biyu ta hanyar gwajin matsayi mai lamba log-rank wanda aka raba ta amfani da abubuwan da bazuwar. Maƙasudin ƙarshe na biyu ta hanyar kimantawa na masu bincike sun haɗa da rayuwa ba tare da ci gaba ba (PFS), ƙimar amsawar manufa (cORR), ƙimar sarrafa cututtuka (DCR), da aminci.
Sakamako:
A lokacin yanke bayanai (Oktoba 24, 2024), an sanya maki 494 (T-DXd, n = 246; RAM + PTX, n = 248). Dangane da abubuwan da suka faru na OS 266 da aka lura (ƙasa na bayanai = 78.5%), an sami fifikon inganci (P mai gefe biyu < 0.0228). Tsarin bin diddigin OS na matsakaici (m) (95% CI) shine watanni 16.8 (14.0-20.0) don T-DXd da watanni 14.4 (13.1-19.7) don RAM + PTX. mOS (95% CI) shine watanni 14.7 (12.1-16.6) don T-DXd vs watanni 11.4 (9.9-15.5) don RAM + PTX (rabowar haɗari [HR], 0.70; P = 0.0044). Ƙarin bayanai masu inganci suna cikin Tebur. Tsawon lokacin magani (tsakanin lokaci) shine watanni 5.4 (0.7-30.3) tare da T-DXd da watanni 4.6 (0.9-34.9) tare da RAM + PTX. An ruwaito abubuwan da suka faru na rashin lafiya (TEAEs) a cikin 244/244 (100%) idan aka kwatanta da 228/233 maki (97.9%) tare da T-DXd idan aka kwatanta da RAM + PTX, bi da bi; 68.0% idan aka kwatanta da 73.8% sun kasance maki (G) ≥3. TEAE masu tsanani tare da T-DXd idan aka kwatanta da RAM + PTX sun faru a cikin 41.0% idan aka kwatanta da 43.3% na maki; TEAEs da ke da alaƙa da dakatar da magani sun faru a cikin 14.3% idan aka kwatanta da 17.2% na maki. An yi wa marasa lafiya magani da aka yi musu magani bisa ga ka'ida, sakamakon cutar huhu/ciwon huhu da ya shafi interstitial, a cikin maki 34 (13.9%), tare da T-DXd (1 G3, 0 G4/5) idan aka kwatanta da maki 3 (1.3%), tare da RAM + PTX (2 G3, 1 G5).
A halin yanzu, har yanzu akwai gwaje-gwaje da yawa na asibiti na sabbin fasahohin yaƙi da cutar kansa a China waɗanda ke neman marasa lafiya. Tuntuɓi kan sabbin magunguna da fasahohi, zaku iya tuntuɓar Sashen Ƙasa da Ƙasa na Asibitin Oncology na Yankin Kudu na Beijing.
Lambar Waya: 4008803716
Email：myimmnet@163.com
Lokacin Saƙo: Yuli-22-2025