BeiGene’s Brukinsa gets Europe approval for follicular lymphoma (NASDAQ:BGNE)
Brukinsa was approved for use in combination with obinutuzumab in adult patients who have received at least two prior lines of systemic therapy.
This is the fourth indication for the drug in the EU after chronic lymphocytic leukemia, marginal zone lymphoma, and Waldenström’s macroglobulinemia. Brukinsa is now approved for a wider patient population in the region than any other Bruton’s tyrosine kinase (BTK) inhibitor.
Mehrdad Mobasher, Chief Medical Officer at BeiGene (BGNE), said: “Brukinsa is now the first BTK inhibitor approved in this indication and has the broadest label of any medicine in its class globally.”
In the U.S., Brukinsa last received approvals for additional indications in January, for chronic lymphocytic leukemia and small lymphocytic lymphoma. The oncologic was already approved for Waldenström’s macroglobulinemia, marginal zone lymphoma, and mantle cell lymphoma.