Kukadzi 2023: Zanubrutinib (Brukinsa, BeiGene USA, Inc.) inotenderwa neFDA kune chronic lymphocytic leukemia (CLL) kana small lymphocytic lymphoma (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 yakaongorora kushanda kwevarwere vane kudzokazve kana kuti refractory CLL/SLL (NCT03734016). Vatori vechikamu mazana matanhatu nemakumi mashanu nevaviri vakaiswa kuzanubrutinib kana ibrutinib zvisina tsarukano. 652 yaiva nhamba yepakati yemitsara yapfuura yekurapa (renji 1-1). ORR neDOR ndivo vaive vekutanga efficacy mhedzisiro matanho panguva ino mukuongororwa kwemhinduro, maererano neIRC. Iyo ORR yezanubrutinib ruoko yaive 8% (80% CI: 95, 76) uye yeibrutinib ruoko yaive 85% (73% CI: 95, 68) (response rate ratio: 78, 1.10% CI: 95, 1.01; p=1.20). Mushure mekutevera kwepakati kwemwedzi 0.0264, hapana ruoko rwakanga rwasvika paMedian DOR.
Migumisiro yakajairika yezanubrutinib (30%) yaisanganisira kubuda ropa (42%), kuderera kwehutachiona hwehutachiona (39%), kuderera kweplatelet count (34%), kuderera kweutrophil count (42%), uye kurwadziwa kwemusculoskeletal (30%). . Muchikamu che13% chevanhu, zvirwere zvechipiri zvekutanga, zvakadai se-non-skin carcinomas, zvakaitika. 3.7% yevarwere vaive neatrial fibrillation kana flutter, nepo 0.2% yevarwere vaive neventricular arrhythmias giredhi 3 kana pamusoro.
Kusvikira chirwere ichi chichienderera mberi kana kuti kune huturu husingagoneki, iyo yakakurudzirwa zanubrutinib dosage ndeye 160 mg inotorwa nemuromo kaviri zuva kana 320 mg inotorwa nemuromo kamwe chete zuva nezuva.
View full prescribing information for Brukinsa.
