I-National Medical Products Administration (NMPA) yaseShayina Igunyaza i-PADCEVTM ngokuhlanganiswa ne-KEYTRUDA (pembrolizumab) yokwelapha umdlavuza wesinye othuthukisiwe

Ngomhlaka-8 Januwari 2025, i-National Medical Products Administration (NMPA) yaseShayina ivumile i-PADCEVTM (enfortumab vedotin) ngokuhlanganiswa ne-KEYTRUDA (pembrolizumab) yeziguli ezindala ezinomdlavuza we-urothelial othuthukisiwe endaweni noma osakazeke kakhulu (la/mUC).

Ukuvunyelwa kwe-NMPA kwe-enfortumab vedotin kanye ne-pembrolizumab kusekelwa yimiphumela evela esivivinyweni sezokwelapha seSigaba sesi-3 se-EV-302 (esaziwa nangokuthi i-KEYNOTE-A39). Isivivinyo sibonise ukuthi inhlanganisela yokwelashwa ithuthukise ukusinda okujwayelekile okuphakathi (OS) kanye nokusinda okungenayo i-progression-free (PFS) ngemiphumela ebalulekile ngokwezibalo kanye nencazelo yezokwelapha ezigulini ezine-la/mUC engalashwanga ngaphambilini uma kuqhathaniswa ne-chemotherapy equkethe i-platinum. I-OS ephakathi yezinyanga ezingu-31.5 (95% CI: 25.4-NR) yatholakala ngenhlanganisela yokwelashwa uma kuqhathaniswa nezinyanga ezingu-16.1 (95% CI: 13.9-18.3) nge-chemotherapy equkethe i-platinum, okumele ukwehla okungu-53% kwengozi yokufa (Isilinganiso Sengozi [HR]=0.47; Isikhawu Sokuqiniseka esingu-95% [CI]: 0.38-0.58; P<0.00001). I-PFS emaphakathi yezinyanga ezingu-12.5 (95% CI: 10.4-16.6) ibikwe ngenhlanganisela yokwelashwa uma kuqhathaniswa nezinyanga ezingu-6.3 (95% CI: 6.2-6.5) nge-chemotherapy equkethe i-platinum, okumele ukwehla okungu-55% kwengozi yokuqhubeka komdlavuza noma ukufa (HR=0.45; 95% CI: (0.38-0.54); P<0.00001). Imiphumela yokuphepha yayihambisana naleyo ebikwe ngaphambilini ngale nhlanganisela yokwelashwa, futhi azikho izinkinga ezintsha zokuphepha ezitholakele.

Mayelana Nomdlavuza Wesinye kanye Nomchamo We-Urothelial
Umdlavuza we-Urothelial, noma umdlavuza wesinye, uqala kumaseli e-urothelial, azungeze i-urethra, esinyeni, i-ureters, i-renal pelvis, kanye nezinye izitho zomzimba.4 Umdlavuza we-Urothelial ubanga u-90% wazo zonke izinhlobo zomdlavuza wesinye futhi ungatholakala nase-renal pelvis, i-ureter, kanye ne-urethra. Uma umdlavuza wesinye ususakazekele ezithweni noma emisipheni ezungezile, ubizwa ngokuthi isifo esithuthukile endaweni. Uma umdlavuza ususakazekele kwezinye izingxenye zomzimba, ubizwa ngokuthi isifo esithuthukile.8 Cishe u-12% wamacala umdlavuza we-urothelial osethuthukile endaweni noma osethuthukile lapho kutholakala ukuthi unesifo.

EShayina, izinga lokwanda komdlavuza wesinye ngo-2022 libekwe endaweni ye-11 phakathi kwazo zonke izinhlobo zomdlavuza, kanti amacala amasha angaphezu kuka-92,000 atholakale ngalowo nyaka. Ukusabalala komdlavuza wesinye iminyaka emihlanu eShayina kulinganiselwa ukuthi kuyi-2.5/100,000, noma amacala angu-276,102. Ukwelashwa okuqhubekayo nokuqapha kwenza umdlavuza wesinye ube ngowodwa wezinhlobo zomdlavuza ezibiza kakhulu empilweni yesiguli, futhi ube umdlavuza obiza kakhulu uma uqhathaniswa nezinye izifo zomdlavuza.

Mayelana ne-PADCEVTM (enfortumab vedotin)
I-PADCEV (i-enfortumab vedotin) iyi-conjugate yezidakamizwa ezilwa namagciwane (i-ADC) yokuqala eqondiswe ku-Nectin-4, iphrotheni etholakala ebusweni bamaseli futhi ebonakala kakhulu kumdlavuza wesinye. Imininingwane engekho emitholampilo iphakamisa ukuthi umsebenzi we-enfortumab vedotin wokulwa nomdlavuza ubangelwa ukubopha kwayo kumaseli aveza i-Nectin-4, kulandelwe ukufakwa ngaphakathi nokukhululwa kwe-anti-tumor agent i-monomethyl auristatin E (MMAE) esitokisini, okuholela ekutheni iseli lingazali kabusha (ukuboshwa komjikelezo weseli) kanye nokufa kweseli okuhleliwe (i-apoptosis).

I-PADCEV ikhonjiswa eShayina njengokwelashwa okukodwa kokwelapha iziguli ezindala ezinomdlavuza we-urothelial osezingeni eliphezulu noma osakazeka kalula ngemuva kokwelashwa kwangaphambilini nge-chemotherapy equkethe i-platinum kanye ne-programmed death receptor-1 (PD-1) noma i-programmed death-ligand 1 (PD-L1) inhibitors, kanye nokuhlanganiswa ne-KEYTRUDA (pembrolizumab) yeziguli ezindala ezinomdlavuza we-urothelial osezingeni eliphezulu noma osakazeka kalula.

Njengamanje, kusenezivivinyo eziningi zemitholampilo zobuchwepheshe obusha bokulwa nomdlavuza eShayina ezifuna iziguli. Ukubonisana ngemithi emisha kanye nobuchwepheshe, ungaxhumana noMnyango Wezizwe Ngezizwe Wesibhedlela iBeijing South Region Oncology.

Inombolo yocingo: 4008803716

Email：myimmnet@163.com

Izinkomba

1.国家药品监督管理局 (nmpa.gov.cn)

2.Ikhasi lasekhaya le-Astellas | Inkampani Astellas Pharma Inc.

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