Ua ʻāpono ka National Medical Products Administration (NMPA) o Kina iā PADCEVTM i hui pū ʻia me KEYTRUDA (pembrolizumab) no ka mālama ʻana i ka maʻi ʻaʻai ʻōpū holomua

Ma Ianuali 8, 2025, ua ʻāpono ka National Medical Products Administration (NMPA) o Kina i ka PADCEVTM (enfortumab vedotin) i hui pū ʻia me KEYTRUDA (pembrolizumab) no nā poʻe maʻi makua me ka maʻi ʻaʻai urothelial kūloko a i ʻole metastatic (la/mUC).

Ua kākoʻo ʻia ka ʻae ʻana o ka NMPA i ka enfortumab vedotin i hui pū ʻia me ka pembrolizumab e nā hopena mai ka hoʻokolohua lapaʻau Phase 3 EV-302 (i ʻike ʻia hoʻi ʻo KEYNOTE-A39). Ua hōʻike ka hoʻokolohua ua hoʻomaikaʻi ka hui lāʻau lapaʻau i ka median overall survival (OS) a me ka median progression-free survival (PFS) me nā hopena koʻikoʻi a me ke ʻano lapaʻau i nā maʻi me ka la/mUC i mālama ʻole ʻia ma mua i hoʻohālikelike ʻia me ka chemotherapy platinum-loaʻa. Ua hoʻokō ʻia kahi OS median o 31.5 mau mahina (95% CI: 25.4-NR) me ka hui lāʻau lapaʻau i hoʻohālikelike ʻia me 16.1 mau mahina (95% CI: 13.9-18.3) me ka chemotherapy platinum-loaʻa, e hōʻike ana i ka emi ʻana o 53% i ka pilikia o ka make (Hazard Ratio [HR]=0.47; 95% Confidence Interval [CI]: 0.38-0.58; P<0.00001). Ua hōʻike ʻia kahi PFS waena o 12.5 mau mahina (95% CI: 10.4-16.6) me ka hui lapaʻau i hoʻohālikelike ʻia me 6.3 mau mahina (95% CI: 6.2-6.5) me ka chemotherapy i loaʻa ka platinum, e hōʻike ana i ka emi ʻana o 55% i ka pilikia o ka holomua ʻana o ka maʻi kanesa a i ʻole ka make (HR=0.45; 95% CI: (0.38-0.54); P<0.00001). Ua kūlike nā hopena palekana me nā mea i hōʻike mua ʻia me kēia hui lapaʻau, a ʻaʻohe pilikia palekana hou i ʻike ʻia.

E pili ana i ka ʻōpū mimi a me ke kanesa Urothelial
Hoʻomaka ka maʻi ʻaʻai urothelial, a i ʻole ke kanesa ʻōpū, i loko o nā pūnaewele urothelial, ka mea e hoʻopili ana i ka urethra, ka ʻōpū, nā ureters, ka pelvis renal, a me kekahi mau kino ʻē aʻe.4 ʻO ke kanesa urothelial ka 90% o nā maʻi ʻaʻai āpau o ka ʻōpū a hiki ke loaʻa i loko o ka pelvis renal, ureter, a me ka urethra. Inā ua pālahalaha ke kanesa ʻaʻai i nā kino a i ʻole nā ​​​​ʻiʻo e pili ana, ua kapa ʻia ʻo ia he maʻi holomua kūloko. Inā ua pālahalaha ke kanesa i nā ʻāpana ʻē aʻe o ke kino, ua kapa ʻia ʻo ia he maʻi metastatic.8 Ma kahi o 12% o nā hihia he kanesa urothelial holomua kūloko a metastatic paha i ka wā i ʻike ʻia ai.

Ma Kina, ʻo ka nui o ka maʻi ʻaʻai mimi i ka makahiki 2022 ua helu ʻia ma ka helu 11 ma waena o nā maʻi ʻaʻai āpau, me ka ʻoi aku o 92,000 mau hihia hou i ʻike ʻia i kēlā makahiki. ʻO ka nui o nā makahiki ʻelima o ka maʻi ʻaʻai mimi ma Kina ua manaʻo ʻia he 2.5/100,000 mau hihia, a i ʻole 276,102 mau hihia. ʻO ka mālama mau ʻana a me ka nānā ʻana e hoʻolilo i ka maʻi ʻaʻai mimi i kekahi o nā ʻano maʻi ʻaʻai pipiʻi loa i ke ola o ka mea maʻi, a ʻo ke kanesa pipiʻi loa ke hoʻohālikelike ʻia me nā maʻi ʻino ʻē aʻe.

E pili ana i ka PADCEVTM (enfortumab vedotin)
ʻO PADCEV (enfortumab vedotin) kahi hui antibody-drug conjugate (ADC) mua loa o ka papa i kuhikuhi ʻia e kūʻē iā Nectin-4, kahi protein i loaʻa ma ka ʻili o nā cell a hōʻike nui ʻia i loko o ke kanesa ʻōpū. Hōʻike nā ʻikepili nonclinical ʻo ka hana anticancer o enfortumab vedotin ma muli o kona nakinaki ʻana i nā cell Nectin-4-expressing, ukali ʻia e ka internalization a me ka hoʻokuʻu ʻana o ka anti-tumor agent monomethyl auristatin E (MMAE) i loko o ke cell, kahi e hopena ai i ka hana hou ʻole ʻana o ke cell (cell cycle arrest) a me ka make ʻana o nā cell i hoʻolālā ʻia (apoptosis).

Ua hōʻike ʻia ʻo PADCEV ma Kina ma ke ʻano he monotherapy no ka mālama ʻana i nā maʻi makua me ka maʻi kanesa urothelial holomua kūloko a metastatic paha ma hope o ka mālama mua ʻana me ka chemotherapy platinum-containing a me nā mea hoʻopaʻa make programmed-1 (PD-1) a i ʻole programmed death-ligand 1 (PD-L1), a me ka hui pū ʻana me KEYTRUDA (pembrolizumab) no nā maʻi makua me ka maʻi kanesa urothelial holomua kūloko a metastatic paha.

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.

Helu Kelepona：4008803716

Email：myimmnet@163.com

Nā Kuhikuhi

1.国家药品监督管理局 (nmpa.gov.cn)

2.Astellas Home page | ʻO Astellas Pharma Inc.

3.https://www.nejm.org/doi/full/10.1056/NEJMoa2035807