Fierce Pharma March 7, 2024
With a new FDA nod, BeiGene has filled the follicular lymphoma approval gap for BTK inhibitors.
Thursday, the FDA doled out an accelerated approval for BeiGene’s Brukinsa to be used alongside Roche’s anti-CD20 antibody Gazyva to treat follicular lymphoma after at least two prior lines of systemic therapy.
Brukinsa is now the first BTK inhibitor approved to treat follicular lymphoma in the U.S., and it boasts the broadest label within the drug class across various hematology indications, Mehrdad Mobasher, M.D., BeiGene’s chief medical officer of hematology, noted in an interview.
Nevertheless, in late-line follicular lymphoma, the Brukinsa combo will face competition from much-touted CAR-T therapies and bispecific antibodies.
Brukinsa’s approval in this use is based on tumor shrinkage data from...
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