A ranar 3 ga Disamba, 2024, Hukumar Kula da Kayayyakin Lafiya ta Kasa (NMPA) ta amince da maganin Zepzelca (lurbinectedin don allura) don tallatawa ta hanyar shirin bita na fifiko. Ana nuna maganin don maganin manya da ke fama da cutar kansar huhu ta ƙananan ƙwayoyin halitta (SCLC) waɗanda ke fama da ci gaban cututtuka bayan ko bayan maganin chemotherapy na platinum.
Zepzelca magani ne mai hana ƙwayoyin cuta na kansar. Yayin da yake hana ƙwayoyin cuta na kansar, yana daidaita yanayin ƙwayoyin cuta na kansar kuma yana haifar da apoptosis na ƙwayoyin cuta na kansar. Hukumar Abinci da Magunguna ta Amurka (FDA) ta amince da maganin ta hanyar Shirin Amincewa da Sauri a 2020. Tsawon shekaru 27, ita ce kawai sabuwar sinadari da FDA ta amince da ita don maganin sake kamuwa da cutar SCLC tun daga 1997.
Amincewar Zepzelca daga NMPA ta dogara ne akan sakamakon bincike guda biyu na asibiti. Ɗaya daga cikinsu shine wani muhimmin bincike da aka gudanar a ƙasashen waje, wani bincike mai buɗewa, mai cibiya da yawa, da kuma na hannu ɗaya (gwajin kwandon Phase 2) ga manya marasa lafiya da ke fama da SCLC (gami da marasa lafiya masu saurin kamuwa da platinum da marasa jure wa platinum) waɗanda suka fuskanci ci gaban cuta bayan sun sami maganin chemotherapy na platinum. A cikin wannan binciken, an yi musu magani da Zepzelca kaɗai ta hanyar jiƙa maganin ta hanyar jijiya a kowane mako 3 a allurai na 3.2 mg/m2. An buga binciken a cikin The Lancet Oncology, wanda ya nuna jimlar ƙimar amsawa (ORR) na 35.2%, matsakaicin tsawon lokacin amsawa (mDoR) na watanni 5.3, matsakaicin rayuwa ba tare da ci gaba ba (mPFS) na watanni 3.5, da kuma mOS na watanni 9.3 ga duk marasa lafiya da aka yi wa magani da Zepzelca. Wani binciken kuma shi ne wani bincike na asibiti da aka yi da hannu ɗaya, wanda ya haɗa da ƙaruwar allurai da faɗaɗawa ga Zepzelca don tantance amincinsa, juriyarsa, pharmacokinetics (PK), da kuma ingancinsa na farko ga marasa lafiya 'yan China da ke fama da ciwon daji mai tsanani, gami da maimaitawar SCLC. Binciken ya nuna ORR na 45.5%, mDoR na watanni 4.2, mPFS na watanni 5.6 da mOS na watanni 11.0 ga marasa lafiya na SCLC da aka yi wa magani da Zepzelca ta hanyar jiko ta hanyar jijiya a kowane mako 3 a allurar 3.2 mg/m2.
Nazarin biyu da aka yi a sama sun nuna gagarumin aikin hana ƙari ga Zepzelca a matsayin magani na biyu ga SCLC tare da ingantaccen bayanin aminci. Bugu da ƙari, binciken da aka gudanar a cikin al'ummar China ya nuna kyakkyawan sakamako ga marasa lafiya.
Bugu da ƙari, ana kuma binciken Zepzelca a gwaje-gwajen asibiti da dama na ƙasashen duniya. A cikin wani bincike na Mataki na 1/2, Zepzelca tare da atezolizumab sun nuna ORR na 66.67%, mPFS na watanni 4.7, da kuma mOS na watanni 14.5 lokacin da aka yi amfani da shi azaman magani na layi na biyu ga marasa lafiya da ke da babban mataki na SCLC. A wani binciken Mataki na 1/2, Zepzelca tare da pembrolizumab sun nuna ORR na 46.4%, mPFS na watanni 5.3, da kuma mOS na watanni 11.1 a matsayin magani na layi na biyu ga marasa lafiya da ke da sake dawowa da SCLC. Bugu da ƙari, ana gudanar da nazarin asibiti da ya shafi Zepzelca tare da mai hana garkuwar jiki a matsayin maganin kulawa na farko ga SCLC, tare da haɗin gwiwa da chemotherapy don maganin sake dawowa da SCLC, da kuma maganin leiomyosarcoma. Waɗannan nazarin an tsara su ne don ci gaba da bincika amfani da maganin a asibiti da yuwuwar warkewa.
Zuwa yanzu, an amince da Zepzelca don tallata shi a ƙasashe da yankuna 17 a duk faɗin duniya. An bai wa Luye Pharma haƙƙin haɓaka da tallata wannan maganin a babban yankin ƙasar Sin, Hong Kong, da Macao, kuma ta sami amincewar tallata maganin a waɗannan yankuna uku.
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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Nassoshi
1.2024年12月03日药品批准证明文件送达信息 (nmpa.gov.cn)
2.绿叶制药宣布治疗小细胞肺癌创新药赞必佳® （注射用芦比替定）获得国家药品监督管理局上市批准 – 新黶卶动态 – 绿叶动态 – 绿叶动态(luye.cn)
Lokacin Saƙo: Janairu-14-2025