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(ECNS) -- Chinese biopharmaceutical company BeiGene has won accelerated approval from the United States Food and Drug Administration (FDA) as a treatment for mantle cell lymphoma (MCL) in adult patients who have received at least one prior therapy.
The Beijing-based company became the first in China to win FDA approval for its homegrown anti-cancer drug Brukinsa (zanubrutinib). It marks a historical milestone in China’s biopharmaceutical sector as well as toward the company’s goal of transforming treatment for cancer patients around the world.
The FDA approval is based on efficacy results from two single-arm clinical trials, with independent review committee-assessed ORR per 2014 Lugano Classification as the primary endpoint. Across both trials, Brukinsa achieved an ORR, which is the sum of complete responses and partial responses, of 84 percent.
“Today’s FDA approval of Brukinsa, following the previously granted Breakthrough Therapy designation in this indication, validates it as an important treatment option for people with relapsed or refractory MCL,” said John V. Oyler, chairman, co-founder and CEO of BeiGene.