Fourth accelerated accreditation at Duchenne?  Sarepta gets priority review for gene therapy under FDA scrutiny - Endpoints News

The FDA lit green BeiGene’s Brukinsa for use in chronic lymphocytic leukemia, an approval that is expected to significantly expand the market for the drug in the United States after it overtook the current leading therapy in a trial.

The approval, which is for relapsed/refractory and first-line treatment for adults with CLL as well as small lymphocytic lymphomas, is the drug’s fourth U.S. approval. It comes after BeiGene showed the twice-daily oral drug beat the standard of care, AbbVie and Johnson & Johnson’s Imbruvica, in a head-to-head test.

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