According to a story from BioSpace, the biopharmaceutical company BeiGene Co., Ltd has recently announced that its drug zanubrutinib (marketed as BRUKINSA) has earned Accelerated Approval from the US Food and Drug Administration (FDA). This designation was earned as a treatment for mantle cell lymphoma in patients that have received treatment with a minimum of one previous therapy. BeiGene is focused on the development of immunotherapies and targeted drugs for treating cancer.
About Mantle Cell Lymphoma
Mantle cell lymphoma is a rare type of non-Hodgkin’s lymphoma. There are only about 15,000 patients in the US. This blood cancer affects B-cells, a type of white blood cell. The risk factors for mantle cell lymphoma are not particularly well known; however, acquired genetic mutations in the affected cells are what eventually causes them to become malignant. Most patients are diagnosed in their 60s. In many cases, the disease is not diagnosed until it has reached an advanced stage. Symptoms include fever, night sweats, enlarged spleen and lymph nodes, and weight loss. Treatment options include immunotherapy, chemotherapy, and targeted therapies. Mantle cell lymphoma often relapses after treatment with chemotherapy. Prognosis is difficult to predict; the five year survival rate is 50 percent, but this figure improves to 70 percent with limited-stage disease. To learn more about mantle cell lymphoma, click here.
About Accelerated Approval
The FDA’s Accelerated Approval program allows for the more rapid approval of drugs that are intended to treat serious diseases and can satisfy a currently unmet medical need. Drugs under this approval are cleared based on the results of a surrogate endpoint. These endpoints do not demonstrate clinical efficacy but are commonly believed to predict clinical efficacy. If a drug is passed with this program, the sponsor company is still expected to continue clinical studies in order to prove clinical benefit before receiving permanent approval.
The approval of BRUKINSA follows data from two clinical trials in which the drug was able to produce an overall response rate (ORR) of 84 percent. In the first trial, the complete response rate was 59 percent; in the second, the complete response rate was 22 percent. While these results are encouraging, BRUKINSA will continue to be evaluated under different endpoints to determine its clinical impact.
The drug will be made available on the US market in the next few weeks.
