- The US FDA has expanded the approval of BeiGene's ( NASDAQ: BGNE ) Brukinsa (zanubrutinib) to include chronic lymphocytic leukemia and small lymphocytic lymphoma.
- The oncologic was already approved for Waldenström’s macroglobulinemia, marginal zone lymphoma, and mantle cell lymphoma.
- Earlier Thursday, regulators in the UK also approved Brukinsa for the new lymphoma indications . The European Medicines Agency also recently granted marketing approval.
- In June, the FDA extended the review of Brukinsa for the two new indications to review new data from a phase 3 trial of the drug vs. AbbVie ( ABBV ) and Johnson & Johnson's ( JNJ ) Imbruvica (ibrutinib), another BTK inhibitor.
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BeiGene's Brukinsa gains approval for two additional types of leukemia