Fabrairu 2023: Zanubrutinib (Brukinsa, BeiGene USA, Inc.) an amince da shi ta FDA don cutar sankarar lymphocytic na kullum (CLL) ko ƙananan lymphoma na lymphocytic (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 ya kimanta tasiri a cikin marasa lafiya tare da CLL/SLL da suka sake dawowa ko kuma mai juyayi (NCT03734016). Mahalarta 652 gabaɗaya an ba su bazuwar zuwa ko dai zanubrutinib ko ibrutinib. 1 shine matsakaicin adadin layin jiyya na baya (kewaye 1-8). ORR da DOR sune matakan ingantaccen sakamako na farko a wannan lokacin a cikin nazarin amsawa, a cewar wata IRC. ORR na hannun zanubrutinib shine 80% (95% CI: 76, 85) kuma ga hannun ibrutinib shine 73% (95% CI: 68, 78) (rabin amsawa: 1.10, 95% CI: 1.01, 1.20; p=0.0264). Bayan bin tsaka-tsaki na watanni 14.1, kowane hannu bai kai matsakaicin DOR ba.
Mafi yawan illolin zanubrutinib (30%) sun haɗa da zub da jini (42%), ƙananan ƙwayar cuta na numfashi (39%), raguwar adadin platelet (34%), rage yawan neutrophil (42%), da ciwon musculoskeletal (30%). . A cikin kashi 13 cikin ɗari na ɗaiɗaikun mutane, cututtukan farko na sakandare, irin su carcinomas marasa fata, sun faru. 3.7% na marasa lafiya suna da fibrillation na atrial ko flutter, yayin da 0.2% na marasa lafiya suna da ventricular arrhythmias 3 ko sama.
Har sai cutar ta ci gaba ko kuma akwai guba maras iya jurewa, shawarar zanubrutinib shawarar shine 160 MG da ake sha da baki sau biyu a rana ko kuma 320 MG ana sha baki ɗaya sau ɗaya kowace rana.
View full prescribing information for Brukinsa.
