BeiGene, Ltd. and Nanolek announced that BRUKINSA? (zanubrutinib) has received approval from the Russia Ministry of Health for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. BeiGene and Nanolek entered into an exclusive distribution agreement for Nanolek to commercialize BRUKINSA in the Russian Federation. Marketing approval for BRUKINSA for the treatment of MCL in Russia is based on results from two single-arm clinical trials. Across both trials, as assessed by independent review committee (IRC) per 2014 Lugano Classification, BRUKINSA achieved an overall response rate (ORR) of 83.7%, defined as the combined rate of complete responses (CRs) and partial responses (PRs). Of the 118 patients with MCL who received at least one prior therapy and received BRUKINSA treatment, serious adverse reactions occurred in 36 patients (31%), with the most frequent being pneumonia (11%) and bleeding (5%). Eight patients (7%) discontinued treatment due to adverse reactions in the trials, with the most frequent being pneumonia (3.4%), and one patient (0.8%) experienced an adverse reaction that led to dose reduction. The recommended dose of BRUKINSA is either 160 mg twice daily or 320 mg once daily, taken orally with or without food. The dose may be adjusted for adverse reactions and reduced for patients with severe hepatic impairment and certain drug interactions.