Site Editors
Shaji K. Kumar, MD
Prashant Kapoor, MD, FACP
Shaji K. Kumar, MD
Prashant Kapoor, MD, FACP
Posted: Monday, February 26, 2024
On February 20, Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental biologics license application for teclistamab-cqyv (Tecvayli) for a reduced dosing frequency of 1.5 mg/kg every 2 weeks (Q2W) in patients with relapsed or refractory multiple myeloma who have achieved and maintained a complete response or better for at least 6 months. This approval would allow increased flexibility in dosing schedule for appropriate patients with a weight-based regimen.
Teclistamab, which was the first bispecific antibody targeting B-cell maturation antigen on multiple myeloma cells and CD3 on T cells to activate an immune response, is administered subcutaneously. It was approved in October 2022 for the treatment of adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy (including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody).
This approval is based on results from the phase I/II MajesTEC-1 study. In this trial, patients were initially treated with the recommended phase II dose of 1.5 mg/kg of teclistamab weekly administered subcutaneously. Patients who achieved a confirmed complete response or better for at least 6 months were eligible to reduce the dosing frequency to 1.5 mg/kg Q2W until disease progression or unacceptable toxicity.
Warnings and precautions with teclistamab focus on cytokine-release syndrome, neurologic toxicity (eg, immune effector cell–associated neurotoxicity syndrome), hepatoxicity, infections, neutropenia, and embryofetal toxicity. The most common adverse reactions (≥ 20%) were pyrexia, cytokine-release syndrome, musculoskeletal pain, injection-site reaction, fatigue, upper respiratory tract infection, nausea, headache, pneumonia, and diarrhea. The most common grade 3 or 4 laboratory abnormalities (≥ 20%) were decreased lymphocytes, decreased neutrophils, decreased white blood cells, decreased hemoglobin, and decreased platelets.
Teclistamab is available only through a restricted program under a Risk Evaluation and Mitigation Strategy. For more on the use of this agent, see the prescribing information.
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