The Russia Ministry of Health has approved BeiGene’s Brukinsa (zanubrutinib) to treat patients with relapsed or refractory mantle cell lymphoma (MCL).
Brukinsa is Bruton’s tyrosine kinase (BTK) molecule inhibitor and is currently being evaluated as a monotherapy as well as in combination with other therapeutics for the treatment of several B-cell malignancies.
The regulatory approval is based on data obtained from two single-arm clinical trials, which were assessed by independent review committee (IRC) per 2014 Lugano Classification.
The studies were conducted in 118 patients with MCL who have received at least one prior therapy.
They demonstrated that Brukinsa achieved 83.7% of overall response rate (ORR).
BeiGene Hematology chief medical officer Jane Huang said: “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.
“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.”
The drug is already approved for MCL treatment in nine countries that include the US, China, UAE, Chile, Brazil, Singapore, Israel, Canada and Australia.
It is recommended to take either 320mg once or 160mg twice a day with or without food orally.
Furthermore, biopharmaceutical firm Nanolek has signed an exclusive distribution agreement with BeiGene to commercialise Brukinsa in Russia.
Nanolek president Vladimir Khristenko said: “Together, we are committed to delivering innovative therapies for the benefit of people impacted by cancer in Russia.”