Kekemapa 3, 2024, ua ʻāpono ʻia ka lāʻau lapaʻau hou ʻo Zepzelca (lurbinectedin no ka injection) no ke kūʻai aku ʻana e ka National Medical Products Administration (NMPA) o Kina ma o ka papahana loiloi koʻikoʻi. Ua hōʻike ʻia ka lāʻau lapaʻau no ka mālama ʻana i nā poʻe maʻi makua me ka maʻi kanesa māmā liʻiliʻi metastatic (SCLC) me ka holomua o ka maʻi ma luna a ma hope paha o ka chemotherapy platinum-based.
He mea hoʻopaʻa koho ʻo Zepzelca i ka transcription oncogenic. ʻOiai ke kāohi nei i ka transcription oncogenic, hoʻoponopono ia i ka microenvironment no nā tumors a alakaʻi i ka apoptosis o nā cell tumor. Ua ʻae ʻia hoʻi ka lāʻau lapaʻau e ka US Food and Drug Administration (FDA) ma o kāna Accelerated Approval Program i ka makahiki 2020. No 27 mau makahiki, ʻo ia wale nō ka mea kemika hou i ʻae ʻia e ka FDA no ka mālama ʻana i ka relapsed SCLC mai ka makahiki 1997.
Ua hoʻokumu ʻia ka ʻae ʻia ʻana o Zepzelca e ka NMPA ma nā hopena o ʻelua mau haʻawina lapaʻau. ʻO kekahi o lākou he haʻawina koʻikoʻi i mālama ʻia ma nā ʻāina ʻē, kahi haʻawina open-label, multicenter, a me ka lima hoʻokahi (kahi hoʻokolohua hīnaʻi Phase 2) i nā poʻe maʻi makua me SCLC (me nā poʻe maʻi platinum-sensitive a me platinum-resistant) i ʻike i ka holomua o ka maʻi ma hope o ka loaʻa ʻana o ka chemotherapy platinum-based. Ma kēia haʻawina, ua mālama ʻia lākou me Zepzelca wale nō ma o ka hoʻokomo ʻana o ka lāʻau i loko o ka intravenous i kēlā me kēia 3 pule ma kahi mahele o 3.2 mg/m2. Ua paʻi ʻia ke aʻo ʻana ma The Lancet Oncology, kahi i hōʻike i ka helu pane holoʻokoʻa (ORR) o 35.2%, ka lōʻihi waena o ka pane (mDoR) o 5.3 mahina, ka median progression-free survival (mPFS) o 3.5 mahina, a me ka mOS o 9.3 mahina no nā poʻe maʻi āpau i mālama ʻia me Zepzelca. ʻO ke aʻo ʻē aʻe he lima hoʻokahi, e hoʻopili ana i ke aʻo lapaʻau me ka hoʻonui ʻana i ka nui a me ka hoʻonui ʻana no Zepzelca e loiloi i kona palekana, ka hiki ke hoʻomanawanui, nā pharmacokinetics (PK), a me ka pono mua i nā poʻe maʻi Kina me nā ʻōpū paʻa holomua, me ka SCLC hou. Ua hōʻike ke aʻo ʻana i kahi ORR o 45.5%, kahi mDoR o 4.2 mahina, kahi mPFS o 5.6 mahina a me kahi mOS o 11.0 mahina no nā poʻe maʻi SCLC i mālama ʻia me Zepzelca ma o ka hoʻokomo ʻana i loko o ke koko i kēlā me kēia 3 pule ma kahi nui o 3.2 mg/m2.
Ua hōʻike nā haʻawina ʻelua ma luna i ka hana antitumor koʻikoʻi no Zepzelca ma ke ʻano he lāʻau lapaʻau laina lua no SCLC me kahi ʻano palekana e hiki ke hoʻokele ʻia. Eia kekahi, ua hōʻike ka haʻawina i mālama ʻia ma ka heluna kanaka Kina i nā hopena maʻi maikaʻi aʻe.
Eia kekahi, ke noiʻi ʻia nei ʻo Zepzelca ma nā hoʻokolohua lapaʻau honua he nui. Ma kahi noiʻi Phase 1/2, ua hōʻike ʻo Zepzelca i hui pū ʻia me atezolizumab i kahi ORR o 66.67%, kahi mPFS o 4.7 mau mahina, a me kahi mOS o 14.5 mau mahina i ka wā i hoʻohana ʻia ai ma ke ʻano he lāʻau lapaʻau laina ʻelua no nā poʻe maʻi me ka SCLC pae ākea. Ma kahi noiʻi Phase 1/2 ʻē aʻe, ua hōʻike ʻo Zepzelca i hui pū ʻia me pembrolizumab i kahi ORR o 46.4%, kahi mPFS o 5.3 mau mahina, a me kahi mOS o 11.1 mau mahina ma ke ʻano he lāʻau lapaʻau laina ʻelua no nā poʻe maʻi me ka SCLC i hoʻihoʻi ʻia. Eia kekahi, ke hana ʻia nei nā haʻawina lapaʻau e pili ana iā Zepzelca i hui pū ʻia me kahi mea hoʻopaʻa i ka pale ʻana i ka maʻi ma ke ʻano he lāʻau mālama laina mua no SCLC, i hui pū ʻia me ka chemotherapy no ka mālama ʻana i ka SCLC i hoʻihoʻi ʻia, a no ka mālama ʻana i ka leiomyosarcoma. Ua hoʻolālā ʻia kēia mau haʻawina e hoʻomau i ka ʻimi ʻana i ka noi lapaʻau a me ka hiki ke hoʻōla o ka lāʻau.
A hiki i kēia lā, ua ʻae ʻia ʻo Zepzelca no ke kūʻai aku ʻana ma 17 mau ʻāina a me nā ʻāpana o ka honua holoʻokoʻa. Ua hāʻawi ʻia iā Luye Pharma nā kuleana e hoʻomohala a kūʻai aku i kēia lāʻau lapaʻau ma ka ʻāina nui o Kina, Hong Kong, a me Macao, a ua loaʻa iā ia ka ʻae kūʻai aku no ka lāʻau lapaʻau ma kēia mau ʻāpana ʻekolu.
I kēia manawa, nui nā hoʻokolohua lapaʻau o nā ʻenehana anti-cancer hou ma Kina e ʻimi nei i nā maʻi. I ke kūkākūkā ʻana i nā lāʻau lapaʻau a me nā ʻenehana hou, hiki iā ʻoe ke hoʻokaʻaʻike aku i ka Beijing South Region Oncology Hospital International Department.
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Ka manawa hoʻouna: Ian-14-2025