released January 26, 2021
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The United States Food and Drug Administration announced on Thursday it would grant accelerated approval to Chinese biomedicine company BeiGene Ltd's Brukinsa (zanubrutinib) capsules, for the treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy.
That marks the first US FDA approval for a cancer therapy independently developed by a Chinese drug company.
The accelerated approval is based on overall response rate, or how many patients experience a complete or partial shrinkage of their tumors after treatment.
Mantle cell lymphoma, or MCL, is a rare, aggressive form of non-Hodgkin's lymphoma, which is a cancer developing from lymphocytes, a type of white blood cell. It usually responds well to initial treatment but eventually returns or stops responding, and cancer cells continue to grow.
In the US, MCL represents 3 to 10 percent of all non-Hodgkin's lymphoma. By the time it is diagnosed, MCL has usually spread to the lymph nodes, bone marrow and other organs. In relapsed lymphoma, the disease reappears or grows again after a period of remission, while in refractory lymphoma, the disease does not respond to treatment or responds only briefly,according to FDA's press announcement.
A single-arm clinical trial of Brukinsa included 86 patients with MCL who received at least one prior treatment. In the trial, 84 percent 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.
The trial was supported by an additional single-arm trial that included 32 patients, in which 84 percent of patients had tumor shrinkage with a median duration of response of 18.5 months.
John V. Oyler, chairman, co-founder and CEO of BeiGene, said in a press release as the company continues to evaluate Brukinsa's potential in other hematologic cancers, it hopes the FDA approval is the first of many for the therapy.
Since Brukinsa was granted accelerated approval, which enables the FDA to approve drugs for serious conditions to fill an unmet medical need based on a result that is reasonably likely to predict a clinical benefit to patients, further clinical trials may be required to verify and describe Brukinsa's clinical benefit, according to the FDA.
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