This marks the first regulatory approval for BRUKINSA in Russia
BRUKINSA is now approved for the treatment of MCL in ten countries, following the U.S., China, Canada, Australia, and others
BeiGene is committed to rapidly advancing the global registration of BRUKINSA on its own and alongside strategic collaborators
Under an exclusive distribution agreement, Nanolek will commercialize BRUKINSA in Russia
CAMBRIDGE, Mass. & BEIJING & MOSCOW–(BUSINESS WIRE)– BeiGene (NASDAQ: BGNE; HKEX: 06160), a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide, and Nanolek, a biopharmaceutical company specializing in the production of import-substituting and innovative drugs in Russia, today 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.
“The registration of BRUKINSA (zanubrutinib), a next-generation BTK inhibitor that demonstrated improved clinical benefit while reducing the frequency of certain off-target side effects in MCL, will give physicians and patients another treatment option. BRUKINSA has the potential to give those impacted by MCL in Russia an improved prognosis and a more tolerable therapeutic option,” commented Irina Vladimirovna Poddubnaya, Professor, Academician of Russian Academy of Sciences (RAS), and Head of Oncology Department at the Russian Medical Academy of Postgraduate Education.
“This approval reinforces BRUKINSA’s potential as a best-in-class BTK inhibitor for the treatment of hematological malignancies, and we are pleased to make it available to MCL patients in Russia,” said Jane Huang, M.D., Chief Medical Officer, Hematology, BeiGene. “We are working to improve outcomes for patients living with cancer, wherever they live, and this year have secured 12 regulatory approvals for BRUKINSA in the United States, Canada, Latin America, and the APAC and EMEA regions.”
“We look forward to collaborating with Nanolek to bring a much needed new treatment option to MCL patients in Russia,” said Vitaly Sokolinsky, Senior Director, New Market Development, Russia, at BeiGene. “Today’s approval in MCL highlights our continued expansion into Russia, greater Europe and beyond as we bring our expertise to new markets around the world.”
“We’re proud of this significant achievement for patients and look forward to contributing to BRUKINSA’s growing global footprint through our strong collaboration with BeiGene,” added Vladimir Khristenko, President of Nanolek. “Together, we are committed to delivering innovative therapies for the benefit of people impacted by cancer in Russia.”
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.