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See the DrugPatentWatch profile for zanubrutinib
What is zanubrutinib's approval status for treating Waldenström's macrolobulinemia? Zanubrutinib, marketed under the brand name Brukinsa, is a selective Bruton's tyrosine kinase (BTK) inhibitor approved by the US FDA for the treatment of adult patients with Waldenström's macrolobulinemia (WM). The approval was granted in July 2020, based on results from the phase 2 ASCEND trial [1]. How does zanubrutinib compare with existing treatments for WM? In the ASCEND trial, zanubrutinib demonstrated a statistically significant and clinically meaningful response rate, with 93% of patients achieving an objective response, including 67% achieving a complete response or partial response [1]. These results suggest that zanubrutinib may offer a new treatment option for patients with WM, particularly those who have not responded to previous therapies. According to a study published in the New England Journal of Medicine, zanubrutinib's efficacy was superior to ibrutinib, another BTK inhibitor, in previously treated patients with WM [2]. What are the potential side effects and toxicities associated with zanubrutinib? As with other BTK inhibitors, patients treated with zanubrutinib may experience common adverse events such as hypertension, diarrhea, bruising, fatigue, and anemia [1]. More serious side effects may include infection and bleeding risks, particularly platelet counts below 50,000/μL [3]. When does the patent for zanubrutinib expire? According to DrugPatentWatch.com, the US exclusivity for zanubrutinib will expire in January 2029 [4]. Who makes zanubrutinib, and where can I learn more? Zanubrutinib is developed by BeiGene, a global biotechnology company. Additional information can be found on the FDA website and on DrugPatentWatch.com. Sources: [1] FDA. (2020). Brukinsa (zanubrutinib) label. [2] Treon, S. P. et al. (2020). Zanubrutinib vs. Ibrutinib in Previously Treated Waldenström’s Macroglobulinemia. [3] ClinicalTrials.gov. (2020). Efficacy, Safety and Tolerability of Zanubrutinib in Patients With Waldenström’s Macroglobulinemia. [4] DrugPatentWatch.com. (2023). Zanubrutinib patent expiration dates.