Febraayo 2023: Zanubrutinib (Brukinsa, BeiGene USA, Inc.) waxa ansixisay FDA looguna talagalay lymphocytic leukemia (CLL) ama lymphocytic lymphoma yar (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 waxay qiimeysay waxtarka bukaanada soo noqnoqday ama CLL/SLL (NCT03734016). Ka qaybgalayaasha 652 wadar ahaan ayaa si aan kala sooc lahayn loogu qoondeeyay midkood zanubrutinib ama ibrutinib. 1 waxay ahayd tirada dhexe ee khadadka hore ee daawaynta (qiyaastii 1-8). ORR iyo DOR ayaa ahaa cabbiraadaha natiijada ugu muhiimsan ee wakhtigan ee falanqaynta jawaabta, sida ay sheegtay IRC. ORR ee cududda zanubrutinib waxay ahayd 80% (95% CI: 76, 85) iyo cududda ibrutinib waxay ahayd 73% (95% CI: 68, 78) (saamiga jawaabta jawaabta: 1.10, 95% CI: 1.01, 1.20; p=0.0264). Ka dib dabagal dhexdhexaad ah oo 14.1 bilood ah, labada cudud midkoodna ma gaarin dhexdhexaadka DOR.
Dhibaatooyinka soo noqnoqda ee zanubrutinib (30%) waxaa ka mid ah dhiig-baxa (42%), caabuqa hoose ee habka neef-mareenka (39%), hoos u dhaca tirada platelet (34%), hoos u dhaca tirada neutrophils (42%), iyo xanuunka murqaha (30%) . 13% ee shakhsiyaadka, malignancies aasaasiga ah ee labaad, sida kansarka aan maqaarka ahayn, ayaa dhacay. 3.7% bukaannadu waxay qabeen fibrillation atrial ama flutter, halka 0.2% bukaannadu ay qabaan arrhythmias ventricular 3 ama ka sareeya.
Ilaa uu cudurku ka sii socdo ama uu jiro sun aan loo dulqaadan karin, qiyaasta zanubrutinib ee lagu taliyey waa 160 mg oo afka laga qaato laba jeer maalintii ama 320 mg oo afka laga qaato hal mar maalintii.
View full prescribing information for Brukinsa.
