Kua whakaaetia e te Whakahaere Hua Hauora ā-Motu o Haina (NMPA) te PADCEVTM me te KEYTRUDA (pembrolizumab) hei rongoā mō te mate pukupuku tōngāmimi matatau.

I te 8 o Hānuere, 2025, kua whakaaetia e te Whakahaere Hua Hauora ā-Motu o Haina (NMPA) te PADCEVTM (enfortumab vedotin) me te KEYTRUDA (pembrolizumab) mō ngā tūroro pakeke e pāngia ana e te mate pukupuku urothelial kua horapa ki te rohe, kua horapa rānei ki te toto (la/mUC).

Ko te whakaaetanga a te NMPA mō te enfortumab vedotin me te pembrolizumab e tautokona ana e ngā hua o te whakamātautau haumanu Wāhanga 3 EV-302 (e mōhiotia ana ko KEYNOTE-A39). I whakaatuhia e te whakamātautau i whakapai ake te huinga maimoatanga i te oranga whānui toharite (OS) me te oranga kore-haere-ake toharite (PFS) me ngā hua whai hua ā-tatauranga me te whai tikanga haumanu i roto i ngā tūroro me te la/mUC kāore i rongoatia i mua i te whakataurite ki te chemotherapy kei roto te platinum. I tutuki he OS toharite o te 31.5 marama (95% CI: 25.4-NR) me te huinga maimoatanga i whakaritea ki te 16.1 marama (95% CI: 13.9-18.3) me te chemotherapy kei roto te platinum, e tohu ana i te 53% te whakaiti i te mōrearea o te mate (Hazard Ratio [HR]=0.47; 95% Confidence Interval [CI]: 0.38-0.58; P<0.00001). I pūrongohia he PFS toharite o te 12.5 marama (95% CI: 10.4-16.6) me te huinga maimoatanga, ki te whakaritea ki te 6.3 marama (95% CI: 6.2-6.5) me te chemotherapy kei roto he konukawata, e tohu ana i te 55% te whakaiti i te mōrearea o te whanaketanga o te mate pukupuku, o te mate rānei (HR=0.45; 95% CI: (0.38-0.54); P<0.00001). I rite ngā hua haumaru ki ērā i pūrongohia i mua me tēnei huinga maimoatanga, ā, kāore i kitea he take haumaru hou.

Mō te Pūngāwerewere me te Matepukupuku Urothelial
Ka tīmata te mate pukupuku urothelial, te mate pukupuku pūkahukahu rānei, i roto i ngā pūtau urothelial, e whakarārangi ana i te urethra, te pūkahukahu, ngā ureters, te pelvis whatukuhu, me ētahi atu okana.4 Ko te mate pukupuku urothelial te 90% o ngā mate pukupuku pūkahukahu katoa, ā, ka kitea anō hoki i roto i te pelvis whatukuhu, te ureter, me te urethra. Mena kua horapa te mate pukupuku pūkahukahu ki ngā okana, ki ngā uaua rānei e karapoti ana, ka kiia he mate whānui. Mena kua horapa te mate pukupuku ki ētahi atu wāhanga o te tinana, ka kiia he mate metastatic.8 Tata ki te 12% o ngā take he mate pukupuku urothelial whānui, he mate metastatic rānei i te wā i kitea ai.

I Haina, ko te reiti o te mate pukupuku tōngāmimi i te tau 2022 i tū ki te 11 o ngā mate pukupuku katoa, me te neke atu i te 92,000 ngā kēhi hou i kitea i taua tau. Ko te horapa o te mate pukupuku tōngāmimi i Haina mō ngā tau e rima e kiia ana he 2.5/100,000 kēhi, arā, 276,102 kēhi. Mā te maimoatanga me te tirotiro tonu ka waiho te mate pukupuku tōngāmimi hei tētahi o ngā momo mate pukupuku tino utu nui i te roanga o te oranga o te tūroro, ā, ko te mate pukupuku tino utu nui ina whakaritea ki ētahi atu mate pukupuku.

Mō PADCEVTM (enfortumab vedotin)
Ko te PADCEV (enfortumab vedotin) he hononga paturopi-rongoā tuatahi (ADC) e aro ana ki te Nectin-4, he pūmua kei te mata o ngā pūtau, ā, he nui te whakaputanga i roto i te mate pukupuku tōngāmimi. E kī ana ngā raraunga kore-haumanu ko te mahi ārai mate pukupuku o te enfortumab vedotin nā tōna herenga ki ngā pūtau e whakaatu ana i te Nectin-4, ā, muri iho ka uru ki roto, ka tukuna hoki te kaihoko ārai-pukupuku monomethyl auristatin E (MMAE) ki roto i te pūtau, ka hua ake ko te kore whakaputa uri o te pūtau (te aukati i te huringa pūtau) me te mate pūtau kua whakaritea (apoptosis).

I Haina, kua tohua te PADCEV hei rongoā kotahi mō ngā tūroro pakeke e pāngia ana e te mate pukupuku urothelial kua horapa, kua horapa rānei i muri i te maimoatanga o mua ki te chemotherapy kei roto te platinum me ngā aukati mate kaiwhakawhiwhi mate kua whakaritea-1 (PD-1) me te aukati mate-ligand 1 kua whakaritea-1 (PD-L1), me te whakamahi tahi me te KEYTRUDA (pembrolizumab) mō ngā tūroro pakeke e pāngia ana e te mate pukupuku urothelial kua horapa, kua horapa rānei.

I tēnei wā, he maha tonu ngā whakamātautau haumanu o ngā hangarau hou hei ārai i te matepukupuku i Haina e rapu ana i ngā tūroro. Mēnā kei te hiahia koe ki te kōrero mō ngā rongoā me ngā hangarau hou, ka taea e koe te whakapā atu ki te Tari Ao o te Hōhipera Oncology Rohe Tonga o Beijing.

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Ngā Tohutoro

1.国家药品监督管理局 (nmpa.gov.cn)

2.Astellas Home page | Astellas Pharma Inc.

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