Hukumar Kula da Kayayyakin Lafiya ta Kasa (NMPA) ta amince da PADCEVTM tare da hadin gwiwar KEYTRUDA (pembrolizumab) don magance cutar kansar mafitsara mai tsanani.

A ranar 8 ga Janairu, 2025, Hukumar Kula da Kayayyakin Lafiya ta Kasa ta kasar Sin (NMPA) ta amince da PADCEVTM (enfortumab vedotin) tare da hadin gwiwar KEYTRUDA (pembrolizumab) ga manyan marasa lafiya da ke fama da cutar kansar urothelial (la/mUC) a yankinsu.

Amincewar NMPA na enfortumab vedotin tare da pembrolizumab ya samu goyon baya daga sakamakon gwajin asibiti na Phase 3 EV-302 (wanda kuma aka sani da KEYNOTE-A39). Gwajin ya nuna cewa haɗin maganin ya inganta matsakaicin rayuwa gaba ɗaya (OS) da matsakaicin rayuwa ba tare da ci gaba ba (PFS) tare da sakamako mai mahimmanci da ma'ana a asibiti ga marasa lafiya da ke fama da la/mUC da ba a yi musu magani ba a baya idan aka kwatanta da chemotherapy mai ɗauke da platinum. An cimma matsakaicin OS na watanni 31.5 (95% CI: 25.4-NR) tare da haɗin maganin idan aka kwatanta da watanni 16.1 (95% CI: 13.9-18.3) tare da chemotherapy mai ɗauke da platinum, wanda ke wakiltar raguwar haɗarin mutuwa da kashi 53% (Ratio na Hadari [HR]=0.47; 95% Tazarar Amincewa [CI]: 0.38-0.58; P<0.00001). An bayar da rahoton matsakaicin PFS na watanni 12.5 (95% CI: 10.4-16.6) tare da haɗin maganin idan aka kwatanta da watanni 6.3 (95% CI: 6.2-6.5) tare da maganin chemotherapy mai ɗauke da platinum, wanda ke wakiltar raguwar haɗarin ci gaba da cutar kansa ko mutuwa da kashi 55% (HR=0.45; 95% CI: (0.38-0.54); P<0.00001). Sakamakon aminci ya yi daidai da waɗanda aka ruwaito a baya tare da wannan haɗin maganin, kuma ba a gano sabbin matsalolin tsaro ba.

Game da Ciwon Mafitsara da Ciwon Urothelial
Ciwon daji na mafitsara, ko kuma ciwon daji na mafitsara, yana farawa ne daga ƙwayoyin urothelial, waɗanda ke kewaye da urethra, mafitsara, ureters, pelvis na koda, da wasu gabobin jiki.4 Ciwon daji na mafitsara yana wakiltar kashi 90% na dukkan cututtukan mafitsara kuma ana iya samunsa a cikin ƙugu, ureter, da urethra. Idan ciwon daji na mafitsara ya bazu zuwa ga gabobin jiki ko tsokoki da ke kewaye, ana kiransa cutar da ta bulla a cikin gida. Idan ciwon daji ya bazu zuwa wasu sassan jiki, ana kiransa cutar da ta bulla a cikin gida.8 Kimanin kashi 12% na lokuta suna da cutar kansar mafitsara ta mafitsara ta mafitsara a lokacin ganewar asali.

A ƙasar Sin, yawan kamuwa da cutar kansar mafitsara a shekarar 2022 ya kai matsayi na 11 a cikin dukkan cututtukan daji, inda aka gano sabbin mutane sama da 92,000 a wannan shekarar. An kiyasta cewa yawan kamuwa da cutar kansar mafitsara a ƙasar Sin na tsawon shekaru biyar ya kai 2.5/100,000, ko kuma mutane 276,102. Ci gaba da magani da sa ido kan cutar kansar mafitsara ya sa cutar kansar mafitsara ta zama ɗaya daga cikin nau'ikan ciwon daji mafi tsada a tsawon rayuwar majiyyaci, kuma cutar kansa mafi tsada idan aka kwatanta da sauran cututtukan daji.

Game da PADCEVTM (enfortumab vedotin)
PADCEV (enfortumab vedotin) wani magani ne na farko da aka yi amfani da shi wajen yaƙi da ƙwayoyin cuta (ADC) wanda aka yi amfani da shi wajen yaƙar Nectin-4, wani furotin da ke saman ƙwayoyin halitta kuma yana bayyana sosai a cikin cutar kansar mafitsara. Bayanan da ba na asibiti ba sun nuna cewa aikin enfortumab vedotin na hana ciwon daji yana faruwa ne saboda ɗaure shi da ƙwayoyin da ke bayyana Nectin-4, sannan kuma a saka shi cikin ƙwayoyin halitta da kuma sakin maganin hana ciwon daji na monomethyl auristatin E (MMAE) a cikin ƙwayoyin halitta, wanda ke haifar da rashin sake haihuwa (kamawar zagayowar ƙwayoyin halitta) da kuma mutuwar ƙwayoyin halitta da aka tsara (apoptosis).

Ana amfani da PADCEV a kasar Sin a matsayin maganin da ake amfani da shi wajen magance manyan marasa lafiya da ke fama da cutar kansar urothelial ta hanyar da ba ta da magani ko kuma ta hanyar da ba ta da magani bayan an yi musu magani a baya da maganin chemotherapy mai dauke da platinum da kuma mai karɓar mutuwa mai dauke da kwayar cuta ta death receptor-1 (PD-1) ko kuma mai hana mutuwa ta hanyar da ba ta da magani ...

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.国家药品监督管理局 (nmpa.gov.cn)

2.Shafin Farko na Astellas | Astellas Pharma Inc. girma

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