August 2021: Nivolumab (Opdivo, Bristol-Myers Squibb Co.) parantos disatujuan ku Administrasi Pangan sareng Narkoba pikeun pangobatan adjuvan pasien kalayan karsinoma urothelial (UC) anu résiko luhur kanceuh saatos reseksi radikal.
Ieu mangrupikeun kahiji waktos FDA parantos nyatujuan pangobatan adjuvant pikeun penderita UC anu berisiko tinggi. Papanggihan ogé nyokong kaputusan pikeun ngarobah otorisasina nivolumab pikeun otorisasina pikeun maju / metastatik UC kana persetujuan standar.
Nivolumab diulik dina CHECKMATE-274 (NCT02632409), uji coba acak-dobel, buta dua kali, placebo-dikontrol dina penderita UC tina kandung kemih atanapi saluran kemih luhur (pelvis ginjal atanapi ureter) anu résiko luhur kanceuh dina 120 dinten ti reseksi radikal. Pasién ditugaskeun sacara acak (1: 1) pikeun nampi nivolumab 240 mg atanapi plasebo ku infus intravena unggal dua minggu dugi ka kambuh atanapi karacunan anu teu kaampeuh, kalayan période pangobatan maksimum sataun.
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).
Perkiraan babandingan bahaya DFS anu henteu terstruktur nyaéta 0.83 dina pamariksaan éksplorasi pasien kalayan tumor PD-L1-négatip (58 persén) (95 persén CI: 0.64, 1.08). Kalayan 33 persén maotna dina sakumna penduduk acak, data OS masih di lemburna. Aya 37 maotna dina subpopulasi UTUC (20 dina panangan nivolumab, 17 dina panangan plasebo).
Rashes, capé, diaré, pruritus, nyeri musculoskeletal, sareng inféksi saluran kemih mangrupikeun épék parah anu paling sering dititénan sakitar 20% pamilon anu nampi nivolumab dina CHECKMATE-274.
Nivolumab diresepkeun dina dosis 240 mg unggal dua minggu atanapi 480 mg unggal opat minggu kanggo pangobatan adjuvan UC.
rujukan: https://www.fda.gov/
Pariksa rinci Ieuh.
