BeiGene Ltd’s lymphoma treatment was recently approved by the U.S. Food and Drug Administration. This is the first time a company developed predominantly in China has been approved within America. Brukinsa was studied in 118 patients with mantle cell lymphoma participating in two clinical trials. The patient population was approximately 70% Asian with about 21% of the them being Caucasian and only between 10% to 15% of them from the United States, BeiGene reported.

FDA Accelerated Approval Brings Competition

TrialSite News covered the approval and brings additional information. The FDA extended BeiGene accelerated approval for the mantle cell lymphoma treatment—a capsule-based treatment for adult patients who received at least one prior therapy. The approval came three-months ahead of schedule and will bring competition into the U.S. market for mantle cell lymphoma drugs. This approval represents a breakthrough for innovative Chinese emerging biopharma sponsors targeting Western markets.

What is Mantle Cell Lymphoma?

It is a rare, aggressive form of non-Hodgkin lymphoma (NHL), a blood cancer comprising about 6% of NHL cases. Presently, the United States has about 4,200 cases per year. Mantle cell lymphoma (MCL) results from a malignant transformation of a B lymphocyte in the outer edge of a lymph node follicle (the mantle zone). The transformed B lymphocyte grows in an uncontrolled way, resulting in the accumulation of lymphoma cells, which causes enlargement of lymph nodes. Sometimes, when these lymph nodes become very large, or grow in other parts of the body, they can be called “tumors.” The MCL cells can enter the lymphatic channels and the blood, and can spread to other lymph nodes or tissues, such as the marrow, liver and gastrointestinal tract.

What Drugs Compete for this Patient Group?

BeiGene’s treatment will compete against J&J’ and AbbVie’s Imbruvica, AstraZeneca’s Calquence and Celgene’s Revlimid.

What is the drug’s Cost?

According to some reports, Brukinsa will cost, wholesale, $12,935 for a 30-day supply. This compares with Imbruvica at $12,613 retail, Calquence $14.2,000 per month, and Revlimid at $21,000 per month. Undoubtedly, for market share, it will be priced lower after discounts.

Key Studies

A single-arm clinical trial of Brukinsa included 86 patients with mantle cell lymphoma who had received at least one prior treatment. The trial measured how many patients experienced complete or partial shrinkage of their tumors after treatment (overall response rate). In the trial, 84% of patients had tumor shrinkage with a median duration of response (time between the initial response to therapy and subsequent disease progression or relapse) of 19.5 months. This trial was supported by an additional single-arm trial that included 32 patients, in which 84% of patients had tumor shrinkage with a median duration of response of 18.5 months.

Clinical Research Sites

For the key single-arm study the following clinical research sites conducted the study:

Beijing Cancer Hospital, Beijing; Peking Union Medical College Hospital, Beijing; Peking University People’s Hospital, Beijing; Fujian Medical University Union Hospital, Fuzhou, Fujan; Nanfang Hospital, Guangzhou, Guangdong; Henan Cancer Province, Zhengzhou, Hanan; Tongi Hospital, Tongi Medical College Huazhong University of Science and Technology, Wuhan, Hubei; Jiangsu Province Hospital, Nanjing, Jiangsu; The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu; The First Affiliated Hospital of Jinlin University, Changchun, Jinlin; Fudan University Shanghai Cancer Center, Shanghai, China; Rui Jin Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai; West China Hospital of Sichuan University, Chengdu, Sichuan; Tianjin Hematonosis Hospital, Tianjin, Tianjin; Tianjin Medical University Cancer Institute and Hospital, Tianjin, Tianjin; The First Affiliated Hospital, Zhejiang University, Hangzhou, Zhejian; Zhejian Cancer Hospital, Hangzhou, Zhejiang.

Lead Research/Investigator

Jun Zhu, PhD, Lymphoma Department of Beijing University Cancer Hospital

Source: U.S. Food & Drug Administration

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