What happened

Shares of BeiGene (NASDAQ:BGNE) were soaring 17.9% higher this week as of the market close on Thursday. The big gain came after the U.S. Food and Drug Administration (FDA) approved Brukinsa as a treatment for Waldenström's macroglobulinemia (WM), a rare type of blood cancer.

So what

The FDA approval decision was based on data from a phase 3 study that evaluated Brukinsa in a head-to-head comparison with Imbruvica, a blockbuster blood cancer drug marketed by AbbVie and Johnson & Johnson. Brukinsa outperformed Imbruvica on several fronts in this study.

Two hands holding a card with "FDA approved" printed on it.

Image source: Getty Images.

Brukinsa has already been approved by the FDA as a second-line treatment for another blood cancer, mantle cell lymphoma. The drug generated sales of $42.4 million in the second quarter, up from $7 million in the prior-year period. The FDA's latest approval for Brukinsa in treating WM should help boost BeiGene's sales in future quarters.

Now what

BeiGene won't have to wait long for another potential catalyst. The FDA set a PDUFA date of Sept. 19, 2021, for making an approval decision on Brukinsa as a second-line treatment for marginal zone lymphoma.

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