BeiGene gains FDA breakthrough therapy status for zanubrutinib in mantle cell lymphoma

BeiGene announced that it received a breakthrough therapy designation for its investigational Bruton's tyrosine kinase (BTK) inhibitor zanubrutinib to treat adults with mantle cell lymphoma (MCL) who have received at least one prior therapy. The company said zanubrutinib, also known as BGB-3111, is being evaluated in a broad clinical programme as a monotherapy and in combination with other therapies to treat various B-cell malignancies.  

BeiGene chief medical officer Jane Huang stated "we believe that the breakthrough therapy designation underscores the potential of zanubrutinib as a meaningful treatment for patients with MCL who have received at least one prior therapy." Zanubrutinib was previously granted fast track designation by the FDA for the treatment of patients with Waldenström's macroglobulinaemia.  

The news comes after BeiGene disclosed in November that the therapy was granted priority review in China for the treatment of patients with relapsed or refractory MCL. In Phase II data unveiled last month, the drug was associated with an overall response rate of 83.5 percent, including a complete response rate of 58.8 percent, as well as a 24-week progression-free survival rate estimated at 82 percent among Chinese patients with relapsed or refractory MCL.  

Meanwhile, BeiGene previously raised approximately 7.1 billion Hong Kong, S.A.R., China dollars ($905 million) in an initial public offering on the Hong Kong, S.A.R., China stock exchange in August 2018.

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