According to a press release from the US Food and Drug Administration (FDA), the agency recently approved a new treatment for multiple myeloma, a type of rare blood cancer. The therapy, called teclistamab-cqyv (marketed as Tecvayli), was developed by Janssen Biotech, Inc., and is classified as a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, making it the first therapy of this class to see approval for public use.
About Multiple Myeloma
Multiple myeloma, which is occasionally referred to as plasma cell myeloma, is a blood cancer that affects plasma cells. These are white blood cells that produce antibodies. The overall cause of multiple myeloma is not well understood; however, some risk factors have been identified. These include obesity, family history, smoldering myeloma, and monoclonal gammopathy of undetermined significance. These last two conditions have the potential to develop into multiple myeloma. Symptoms of this cancer include bone pain, infections, anemia, kidney failure, overly thick blood, confusion, fatigue, headaches, and amyloidosis. Treatment includes chemo, stem cell transplant, and other medications for relapsed disease, which is common. Five-year survival rate is 49 percent in the US. To learn more about multiple myeloma, click here.
About Teclistamab-cqyv (Tecvayli)
The drug is designated for use in patients that have been treated with at least four different therapies previously. These must include an anti-CD38 monoclonal antibody, an immunomodulatory therapy, and proteasome inhibitor. The approval follows the results of a clinical trial in which teclistamab was administered to 110 patients who had received the three prior treatments referenced above.
The drug produced a 61.8 percent overall response rate, a response duration of 90.6 percent at six months; 66.5 percent of patients were still responding at nine months. The therapy will ship with a boxed warning for potentially lethal cytokine release syndrome (which appeared in 72 percent of patients) and neurologic toxicity. As a result of the potential for serious side effects, teclistamab will only be accessible via a Risk Evaluation and Mitigation Strategy (REMS) program.
While this new treatment carries the risk of severe adverse effects, it gives patients who have stopped responding to other treatments a new option that can prolong life.
