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RTNominal unchange188.800 0.000 (0.000%)

16/09/2021 14:50

BeiGene (06160) gets accelerated approval from FDA

[ET Net News Agency, 16 September 2021] BeiGene, Ltd. (06160) said BRUKINSA
(zanubrutinib) has received accelerated approval from the U.S. Food and Drug
Administration (FDA) for the treatment of adult patients with relapsed or refractory (R/R)
marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen. (RC)
This accelerated approval is based on overall response rate (ORR). Continued approval
for this indication may be contingent upon verification and description of clinical
benefit in a confirmatory trial.

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