BeiGene's BTK Inhibitor New Indications Marketing Application Accepted by FDA

Source: Guanlan Pharmaceutical

On the evening of May 19, BeiGene announced that the US FDA has accepted its Bruton’s tyrosine kinase (BTK) inhibitor zanubrutinib for the treatment of adults who have previously received at least one CD20-directed therapy New indications for patients with marginal zone lymphoma (MZL) have been applied for the marketing and priority review will be granted.

It is reported that the application is mainly based on the results of a single-arm, open, multi-center phase 2 MAGNOLIA clinical trial of zebutinib for the treatment of patients with relapsed or refractory MZL, and a zebutinib against B-cell malignancies Supporting data from the global Phase 1/2 clinical trials.

According to the data released by BeiGene at the American Society of Hematology (ASH) annual meeting in December 2020, the preliminary results of the MAGNOLIA clinical trial include an overall response rate of up to 74.

Zebutinib is a small molecule inhibitor of BTK independently developed by BeiGene scientists.

In November 2019, Zebutinib received accelerated approval in the United States for the treatment of mantle cell lymphoma (MCL) patients who had received at least one treatment in the past, becoming the first China to receive FDA breakthrough therapy designation and the first to be approved in the United States Independent research and development of new anti-cancer drugs.

So far, Zebutinib has been approved for the following indications in the following regions:

In November 2019, approved in the United States for the treatment of mantle cell lymphoma patients who have received at least one therapy in the past

In June 2020, approved in China for the treatment of adult mantle cell lymphoma patients who have received at least one treatment in the past

In June 2020, approved in China for the treatment of adult patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) who have received at least one treatment in the past

In February 2021, approved in the United Arab Emirates for the treatment of patients with relapsed or refractory MCL

In March 2021, approved in Canada for the treatment of adult patients with Waldenstrom's macroglobulinemia (WM)

At present, in addition to the United States and China, a total of more than 30 zebutinib related listing applications for multiple indications have been submitted and submitted, covering the European Union and more than 20 other countries.

Note: The original text has been deleted