Agusta 2021: Nivolumab (Opdivo, Bristol-Myers Squibb Co.) Cibiyar Abinci da Magunguna ta amince da ita don kula da marasa lafiya da ciwon urothelial carcinoma (UC) waɗanda ke cikin haɗari mai yawa na sake dawowa bayan tsattsauran ra'ayi.
Wannan shine karo na farko da FDA ta amince da maganin adjuvant don masu cutar UC masu haɗari. Sakamakon binciken ya kuma goyi bayan shawarar sauya izinin nivolumab don ci gaba / metastatic UC zuwa daidaitaccen yarda.
An yi nazarin Nivolumab a cikin CHECKMATE-274 (NCT02632409), gwajin bazuwar, makafi biyu, gwajin gwaji a cikin marasa lafiya tare da UC na mafitsara ko mafitsara na urinary fili (ƙwararrun mahaifa ko ureter) waɗanda ke cikin haɗarin sake dawowa cikin kwanaki 120 m resection. An ba da marasa lafiya bazuwar (1: 1) don karɓar nivolumab 240 MG ko placebo ta jiko na ciki kowane mako biyu har sai da sake dawowa ko rashin haƙuri, tare da matsakaicin lokacin jiyya na shekara guda.
A cikin ƙungiyar da aka yi niyya (ITT) kuma a cikin marasa lafiya tare da ciwace-ciwacen daji da ke bayyana PD-L1 ƙasa da 1%, maƙasudin tasiri na farko shine tsirar da ba ta da cuta mai bincike (DFS). An yi amfani da lokacin da za a sake dawowa na farko (na gida urothelial fili, na gida mara lafiya, ko m metastatic) ko mutuwa don ƙayyade DFS. Ga dukkan maƙasudai na farko, an ba da rahoton wani gagarumin ci gaba a cikin DFS a cikin mahalarta kan nivolumab arm vs. placebo a ƙayyadadden bincike na wucin gadi. A cikin nazarin ITT, marasa lafiya da suka samu nivolumab suna da DFS na tsaka-tsaki na watanni 20.8 (95 bisa dari CI: 16.5, 27.6) idan aka kwatanta da watanni 10.8 (95 bisa dari CI: 8.3, 13.9) a cikin marasa lafiya da suka karbi placebo (HR 0.70; 95 bisa dari CI). : 0.57, 0.86; p=0.0008). Marasa lafiya da suka karɓi nivolumab suna da DFS na tsaka-tsakin da ba a samu ba (95 bisa dari tazara tazara: 21.2, ba ƙididdigewa) idan aka kwatanta da watanni 8.4 (lokacin amincewa da kashi 95: 5.6, 21.2) ga waɗanda suka sami placebo (HR 0.55; 95 kashi tazara tazara: 0.39, 0.77; p=0.0005).
Ƙididdigar haɗarin haɗari na DFS wanda ba a bayyana shi ba shine 0.83 a cikin binciken bincike na marasa lafiya tare da ciwace-ciwacen ƙwayar cuta PD-L1 (kashi 58) (95 bisa dari CI: 0.64, 1.08). Tare da kashi 33 na mace-mace a cikin yawan jama'a da bazuwar, bayanan OS har yanzu suna kan jariri. An sami mutuwar mutane 37 a cikin yawan jama'a na UTUC (20 a cikin hannun nivolumab, 17 a hannun placebo).
Rashes, gajiya, gudawa, pruritus, ciwon musculoskeletal, da kamuwa da cuta na urinary sun kasance mafi yawan tasirin da aka gani a kusan 20% na mahalarta waɗanda suka karbi nivolumab a cikin CHECKMATE-274.
An wajabta Nivolumab a kashi na 240 MG kowane mako biyu ko 480 MG kowane mako huɗu don maganin adjuvant na UC.
reference: https://www.fda.gov/
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