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On September 15th, BeiGene announced that the U.
S.
Food and Drug Administration (FDA) has granted accelerated approval to Baiyueze® (Zebutinib) for the treatment of relapsed or refractory patients who have received at least one anti-CD20 treatment Adult patients with sexual (R/R) marginal zone lymphoma (MZL)
.
This accelerated approval is based on overall response rate (ORR) results
.
The subsequent full approval of this indication will depend on whether the confirmatory test can further confirm the patient's clinical benefit
The FDA approval is based on the effectiveness of two single-arm clinical trials.
The primary endpoints of these two trials are ORR evaluated by the Independent Review Committee (IRC) based on the 2014 Lugano classification criteria
.
A multicenter, pivotal Phase 2 MAGNOLIA clinical trial (NCT03846427) evaluated the efficacy of Baiyueze® in R/R MZL patients who have received at least 1 line of anti-CD20 therapy
.
A total of 66 patients were enrolled in the study, 26 of which were extranodal subtypes, 26 were lymph node subtypes, 12 were splenic subtypes, and 4 were unknown subtypes
Another global Phase 1/2 study BGB-3111-AU-003 (NCT02343120) evaluated 20 patients with MZL, including 9 extranodal subtypes, 5 lymph node subtypes, and 6 splenic subtypes
.
Based on the evaluation of CT scan, the ORR obtained by Baiyueze® was 80% (95% CI: 56.
The most common (≥30%) adverse reactions of Baiyueze®, including abnormal detection data in 847 patients, are neutropenia, upper respiratory tract infection, thrombocytopenia, bleeding, lymphopenia, Skin rash and musculoskeletal pain
.
The recommended dosage of Baiyueze® is 160mg twice a day or 320mg once a day, either on an empty stomach or after meals
.
The dosage can be adjusted according to the adverse reaction.
