2023 Pébruari: Zanubrutinib (Brukinsa, BeiGene USA, Inc.) disatujuan ku FDA pikeun leukemia limfositik kronis (CLL) atanapi limfoma limfositik leutik (SLL).
SEQUOIA was used to assess effectiveness in CLL/SLL patients who had not received treatment (NCT03336333). A total of 479 patients were randomized 1:1 to receive either zanubrutinib until disease progression or unacceptable toxicity or bendamustine plus rituximab (BR) for 6 cycles in the randomized cohort that included patients without 17p deletion. Progression-free survival (PFS) was the primary efficacy outcome metric, as established by a separate review committee (IRC). In the zanubrutinib arm, the median PFS was not achieved (95% CI: NE, NE), but in the BR arm, it was 33.7 months (95% CI: 28.1, NE) (HR= 0.42, 95% CI: 0.28, 0.63; p=0.0001). For PFS, the estimated median follow-up was 25.0 months. Zanubrutinib was assessed in 110 patients with previously untreated CLL/SLL with a 17p deletion in a different non-randomized cohort of SEQUOIA. IRC reported an overall response rate (ORR) of 88% (95% CI: 81, 94). After a median follow-up of 25.1 months, the median duration of response (DOR) had not yet been attained.
ALPINE ditaksir efektivitas dina penderita kambuh atanapi refractory CLL / SLL (NCT03734016). 652 pamilon dina total anu acak ditugaskeun boh zanubrutinib atanapi ibrutinib. 1 nyaéta jumlah median tina garis perlakuan saméméhna (rentang 1-8). ORR na DOR éta ukuran hasilna efficacy primér dina titik ieu analisis respon, nurutkeun hiji IRC. The ORR pikeun panangan zanubrutinib éta 80% (95% CI: 76, 85) jeung panangan ibrutinib éta 73% (95% CI: 68, 78) (rasio laju respon: 1.10, 95% CI: 1.01, 1.20; p=0.0264). Saatos median nurutan-up 14.1 bulan, teu panangan geus ngahontal median DOR.
Efek samping anu paling sering tina zanubrutinib (30%) kalebet perdarahan (42%), inféksi saluran pernapasan handap (39%), panurunan jumlah trombosit (34%), panurunan jumlah neutrofil (42%), sareng nyeri musculoskeletal (30%). . Dina 13% individu, malignancies primér sekundér, kayaning carcinomas non-kulit, lumangsung. 3.7% pasien ngagaduhan fibrillation atrium atanapi flutter, sedengkeun 0.2% pasien ngagaduhan aritmia ventricular kelas 3 atanapi langkung luhur.
Dugi panyakitna maju atanapi aya karacunan anu teu kaampeuh, dosis zanubrutinib anu disarankeun nyaéta 160 mg oral dua kali sadinten atanapi 320 mg oral sakali sadinten.
View full prescribing information for Brukinsa.
