The U.S. Food and Drug Administration (FDA) approved teclistamab-cqyv for adult patients with relapsed or refractory (R/R) multiple myeloma (MM). Specifically, the indication is for patients who have received four or more prior lines of therapy.
Teclistamab-cqyv is a bispecific T-cell engager antibody available as an off-the-shelf treatment. The treatment is administered subcutaneously and works by binding to the CD3 receptor on the surface of T cells and the B-cell maturation agent on the surface of MM cells.
The treatment was granted accelerated approval, so data from confirmatory trials may be used to support continued approval. Initial approval was based on the results of a phase II clinical study, MajesTEC-1, which showed an overall response rate of 61.8% among patients.
Teclistamab-cqyv has warnings for cytokine release syndrome and neurologic toxicity. Common adverse reactions associated with the treatment include musculoskeletal pain, pneumonia, injection site reaction, headache, pyrexia, upper respiratory tract infection, nausea, fatigue, and diarrhea.
“As a clinician and researcher, I see first-hand the human toll of this incurable disease,” said investigator Ajai Chari, MD, of the Icahn School of Medicine at Mount Sinai. “The approval of teclistamab, as the first bispecific antibody in [R/R MM], is a meaningful step in helping many of these hard-to-treat patients.”
Source: Johnson & Johnson, October 25, 2022.