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Accelerated approval for a new mantle cell lymphoma drug

By: Lydia L. Kim, Digital Content Editor

The Food and Drug Administration (FDA) has recently granted accelerated approval to BeiGene’s mantle cell lymphoma (MCL) oral therapy, zanubritinib (BRUKINSA).

Zanubritinib’s efficacy was examined through a phase 2 clinical trial (BGB-311-206 / NCT0306970) in the United States, as well as a 1/2 trial in Australia (BGB-3111-AU-003 / NCT 02343120). The trials’ outcomes were measured through overall response rate (ORR).

In the phase 2 trial, the ORR was 84%, with a complete response rate of 59%, and in the 1/2 trial, ORR was also 84%, with a 22% complete response rate.

In addition to its accelerated approval, zanubritinib also has received its orphan and breakthrough designations for MCL.

Please read more about the approval and its implications for healthcare providers here.



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