Posted by Michael Wonder on 15 Jan 2019
BeiGene receives U.S. FDA breakthrough therapy designation for zanubrutinib in mantle cell lymphoma
14 January 2019 - BeiGene today announced that the U.S. FDA has granted breakthrough therapy designation for its investigational Bruton’s tyrosine kinase inhibitor, zanubrutinib, for the treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy.
Zanubrutinib (BGB-3111) is an investigational small molecule inhibitor of Bruton’s tyrosine kinase discovered by BeiGene scientists that is currently being evaluated in a broad pivotal clinical program globally as a monotherapy and in combination with other therapies to treat various B-cell malignancies.
