A ranar 29 ga Agusta, Hukumar Kayayyakin Lafiya ta Ƙasa ta China (NMPA) ta amince da maganin HERNEXEOS® (kwayoyin zongertinib) na Boehringer Ingelheim a matsayin maganin da ba a yi wa magani ba, wanda ya ci gaba a gida, ko kuma wanda ciwon kansar huhu ba ƙaramin ƙwayar halitta ba (NSCLC) ya haifar, wanda ciwon ya haifar da maye gurbi a HER2 (ERBB2) kuma waɗanda suka sami aƙalla layi ɗaya na maganin da aka yi amfani da shi a baya.
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
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Email：myimmnet@163.com
An bayar da izinin sharaɗi bisa ga bayanai daga gwajin Phase Ib Beamion-LUNG 1 (NCT04886804): Wani buɗaɗɗen lakabi, gwajin ƙaruwar allurar Phase I, tare da tabbatar da allurar da faɗaɗa, na zongertinib a matsayin maganin monotherapy ga mutanen da ke da ciwon daji mai ƙarfi wanda ba za a iya cirewa ko kuma wanda ya kamu da cutar ba tare da canjin HER2 ba. Binciken yana da sassa 2. Kashi na farko a buɗe yake ga manya masu nau'ikan ciwon daji daban-daban tare da canje-canjen HER2 waɗanda suka haɗa da maye gurbi, ƙaruwa, yawan bayyanawa da haɗuwa waɗanda maganin da aka yi musu a baya bai yi nasara ba. Kashi na biyu a buɗe yake ga mutanen da ke da ciwon daji na huhu wanda ba ƙaramin ƙwayar halitta ba ne na HER2.
A cikin ƙungiyar 1, jimillar marasa lafiya 75 sun karɓi zongertinib a kan allurar 120 mg. A lokacin da aka yanke bayanai (29 ga Nuwamba, 2024), kashi 71% na waɗannan marasa lafiya (tazara ta amincewa 95% [CI], 60 zuwa 80; P<0.001 akan ma'aunin ≤30%) sun sami amsa ta zahiri; matsakaicin tsawon lokacin amsawa shine watanni 14.1 (95% CI, 6.9 zuwa ba za a iya kimantawa ba), kuma matsakaicin rayuwa ba tare da ci gaba ba shine watanni 12.4 (95% CI, 8.2 zuwa ba za a iya kimantawa ba). Abubuwan da suka faru na rashin lafiya na aji 3 ko sama da haka sun faru a cikin marasa lafiya 13 (17%). A cikin ƙungiyar 5 (marasa lafiya 31), kashi 48% na marasa lafiya (95% CI, 32 zuwa 65) sun sami amsa ta zahiri. Abubuwan da suka faru na rashin lafiya na aji 3 ko sama da haka sun faru a cikin majiyyaci 1 (3%). A cikin rukunin marasa lafiya na 3 (marasa lafiya 20), kashi 30% na marasa lafiya (95% CI, 15 zuwa 52) sun sami tabbataccen amsa mai ma'ana. Abubuwan da suka faru na rashin lafiya na aji 3 ko sama da haka sun faru a cikin marasa lafiya 5 (25%). A cikin dukkan rukunin marasa lafiya uku, babu wani lamari na cututtukan huhu da suka shafi magani da ya faru.
"Abin ƙarfafa gwiwa ne ganin yadda NMPA ke ci gaba da amincewa da yuwuwar zongertinib. Naɗin da aka yi na farko na maganin zongertinib a China ya nuna buƙatar gaggawa ga wannan majiyyaci. Wannan muhimmin mataki ne na gaba don samar da wannan maganin ga ƙarin majiyyata da ke buƙata," in ji Shashank Deshpande, Shugaban Hukumar Gudanarwa a Boehringer Ingelheim.
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
Shaidar WeChat: 17801183037
Email：myimmnet@163.com
Lokacin Saƙo: Satumba-02-2025