Feb XXVIII: Zanubrutinib (Brukinsa, BeiGene USA, Inc.) approbatur a FDA pro leukemia lymphocytica chronica (CLL) vel lymphocytica parva (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.
ALPINUS efficaciam in aegris relapsis vel refractoribus aestimavit CLL/SLL (NCT03734016). 652 Participia totali passim assignata vel zanubrutinib vel ibrutinib. 1 numerus medius erat praecedentium curationis lineae (range 1-8). ORR et DOR exitus praestantiae praecipuae mensurae hoc loco in analysi responsionis, secundum IRC. OrR pro bracchio zanubrutinib erat 80% (95% CI: 76, 85) et pro bracchio ibrutinib erat 73% (95% CI: 68, 78) (ratio rate responsio: 1.10, 95% CI: 1.01, 1.20; p=0.0264). Post medianum insequentes menses 14.1 neutrum brachium perventum est DOR.
Frequentissimi lateris effectus ex zanubrutinib (30%) inclusa sunt sanguinis (42%), infectio tractus respiratorii inferioris (39%), comitem platelettum minutum (34%), comitem neutrophilum minutum (42%), et dolor musculoskeletalis (30%). . In 13% singulorum, malignitates secundae primariae, sicut carcinomata non-cute, facta sunt. 3.7% aegrorum fibrillationem atrialem vel volitantem, cum 0.2% aegrorum arrhythmias ventriculi gradus 3 vel supra habuerunt.
Donec morbus progreditur aut toxicitas intolerabilis est, zanubrutinib dosis commendatur 160 mg ore sumpta bis die vel 320 mg semel in die viva voce sumpta.
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