August 2021: Nivolumab (Opdivo, Bristol-Myers Squibb Co.) waxaa ansixiyay Maamulka Cuntada iyo Dawooyinka ee daaweynta ku -meel -gaarka ah ee bukaannada qaba kansarka kaadi -mareenka (UC) kuwaas oo halis weyn ugu jira soo noq -noqoshada ka dib qalliin xagjirnimo ah.
Tani waa markii ugu horreysay ee FDA ay oggolaato daaweyn wax-ku-ool ah oo loogu talagalay bukaannada UC ee khatarta sare leh. Natiijooyinka ayaa sidoo kale taageeray go'aanka loogu beddelay oggolaanshaha degdegga ah ee nivolumab ee UC sare/metastatic si loo helo oggolaansho caadi ah.
Nivolumab waxaa lagu baray CHECKMATE-274 (NCT02632409), kala-soocid, indho-la ', tijaabo kontoroolka xakamaynta bukaanka qaba UC kaadi haysta ama kaadi-mareenka sare (miskaha kelyaha ama kaadi-mareenka) kuwaas oo halis sare ugu jiray soo noqoshada 120 maalmood gudahood leexasho xagjir ah. Bukaan -socodka ayaa si aan kala sooc lahayn loogu qoondeeyay (1: 1) si ay u helaan nivolumab 240 mg ama placebo faleebo faleebo labadii toddobaadba mar ilaa soo noqoshada ama sumowga aan loo dulqaadan karin, oo leh muddada daaweynta ugu badan hal sano.
In the intent-to-treat (ITT) group and in patients with tumours expressing PD-L1 less than 1%, the primary effectiveness objective was investigator-assessed disease-free survival (DFS). Time to first recurrence (local urothelial tract, local non-urothelial tract, or distant metastatic) or death was used to determine DFS. For all primary objectives, a statistically significant improvement in DFS was reported in participants on the nivolumab arm vs. placebo at a prespecified interim analysis. In the ITT analysis, patients who got nivolumab had a median DFS of 20.8 months (95 percent CI: 16.5, 27.6) compared to 10.8 months (95 percent CI: 8.3, 13.9) in patients who received placebo (HR 0.70; 95 percent CI: 0.57, 0.86; p=0.0008). Patients who received nivolumab had a median DFS of not achieved (95 percent confidence interval: 21.2, not estimable) compared to 8.4 months (95 percent confidence interval: 5.6, 21.2) for those who got placebo (HR 0.55; 95 percent confidence interval: 0.39, 0.77; p=0.0005).
Qiyaasta saamiga halista DFS ee aan sharciyeysnayn waxay ahayd 0.83 baaritaanka sahaminta bukaannada qaba burooyinka PD-L1 (boqolkiiba 58) (95 boqolkiiba CI: 0.64, 1.08). Iyada oo boqolkiiba 33 dhimashada dhammaan dadka la kala soocay, xogta OS -gu weli waa bilow. 37 qof ayaa ku dhimatay UTUC (20 oo ku jira gacanta nivolumab, 17 oo ku taal gacanta placebo).
Nabaro, daal, shuban, cuncun, xanuunka muruqyada, iyo infekshanka kaadi mareenka ayaa ah saameynta ugu daran ee lagu arkay ku dhawaad 20% kaqeybgaleyaasha qaatey nivolumab CHECKMATE-274.
Nivolumab waxaa lagu qoraa qiyaas 240 mg labadii toddobaadba mar ama 480 mg afartii toddobaadba mar si loogu sii daaweeyo UC.
Tixraaca: https://www.fda.gov/
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