Febhuwari 2023: I-Zanubrutinib (Brukinsa, BeiGene USA, Inc.) igunyazwe yi-FDA nge-chronic lymphocytic leukemia (CLL) noma i-lymphocytic lymphoma encane (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.
I-ALpine ihlole ukusebenza kahle kweziguli ezine-CLL/SLL ezibuyele emuva noma eziphikisayo (NCT03734016). Abahlanganyeli abangama-652 sebebonke babelwe ngokungahleliwe kuzanubrutinib noma ibrutinib. I-1 kwakuyinombolo emaphakathi yemigqa yokwelashwa yangaphambilini (ububanzi 1-8). I-ORR ne-DOR bekuyizinyathelo eziyinhloko zemiphumela yokusebenza kahle kuleli phuzu ekuhlaziyweni kwezimpendulo, ngokusho kwe-IRC. I-ORR yengalo yezanubrutinib yayingu-80% (95% CI: 76, 85) kanti ingalo ye-ibrutinib yayingu-73% (95% CI: 68, 78) (isilinganiso sokuphendula: 1.10, 95% CI: 1.01, 1.20; p=0.0264). Ngemva kokulandelela okumaphakathi kwezinyanga ezingu-14.1, akukho ingalo eyayifike ku-DOR emaphakathi.
Imiphumela evame kakhulu yezanubrutinib (30%) yayihlanganisa ukopha (42%), ukutheleleka kwepheshana lokuphefumula eliphansi (39%), ukwehla kwe-platelet count (34%), ukwehla kwe-neutrophil count (42%), nobuhlungu be-musculoskeletal (30%). . Kubantu abangu-13%, izifo zesibili eziyinhloko, njenge-non-skin carcinomas, zenzeka. I-3.7% yeziguli zine-fibrillation ye-atrial noma i-flutter, kuyilapho i-0.2% yeziguli zine-ventricular arrhythmias yebanga lesi-3 noma ngaphezulu.
Kuze kube yilapho isifo siqhubeka noma kunobuthi obungabekezeleleki, umthamo ophakanyisiwe we-zanubrutinib ngu-160 mg othathwe ngomlomo kabili ngosuku noma u-320 mg othathwe ngomlomo kanye ngosuku.
View full prescribing information for Brukinsa.
