BeiGene: FDA to Review Brukinsa Combo in Relapsed, Refractory Follicular Lymphoma
July 12 2023 - 7:48AM
Dow Jones News
By Colin Kellaher
BeiGene on Wednesday said the U.S. Food and Drug Administration
has accepted its application seeking expanded approval of Brukinsa
for certain patients with follicular lymphoma, the most common
slow-growing non-Hodgkin lymphoma.
The Beijing biotechnology company said the application covers
Brukinsa in combination with obinutuzumab for adults with relapsed
or refractor follicular lymphoma after at least two prior lines of
therapy.
BeiGene said the FDA has assigned a target action date in the
first quarter of 2024, adding that approval would mark the fifth
U.S. indication for Brukinsa.
BeiGene reported global Brukinsa sales of $211.4 million for the
first quarter of the year.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
July 12, 2023 07:33 ET (11:33 GMT)
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