 Home > Medical News > Medicines Company News > BeiGene announced that the FDA has accepted the application for new indications of BeiGene for marginal zone lymphoma

BeiGene announced that the FDA has accepted the application for new indications of BeiGene for marginal zone lymphoma

 Last Update: 2021-07-06
 Source: Internet
 Author: User

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BeiGene announced today that the U.
S.
Food and Drug Administration (FDA) has accepted Baiyueze® (Zebutinib) for the treatment of adult marginal zone lymphoma (MZL) patients who have previously received at least one CD20-directed therapy.
New indication listing application (sNDA) and granted priority review qualifications
.

The Prescription Drug Filer Fees Act (PDUFA) is dated September 19, 2021

Dr.
Huang Weijuan, Chief Medical Officer of BeiGene Hematology, said: “This is the company’s first pharmacy application for marginal zone lymphoma
.

In the United States, more than 2,000 people are diagnosed with marginal zone lymphoma each year.

The clinical data of the sNDA comes from the results of a single-arm, open, multi-center phase 2 MAGNOLIA clinical trial (NCT03846427) for the treatment of patients with relapsed or refractory MZL.
Announced at the academic meeting), and supporting data from a global phase 1/2 clinical trial (NCT02343120) of Baiyueze® against B-cell malignancies
.

At the same time, the aggregated safety data of 847 patients who participated in the 7 Baiyueze® clinical trials were also included in the sNDA

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