HORSHAM, Pa. - Johnson & Johnson (NYSE:JNJ) announced today that the U.S. Food and Drug Administration (FDA) has approved a new biweekly dosing regimen for TECVAYLI® (teclistamab-cqyv), offering a more flexible treatment schedule for patients with relapsed or refractory multiple myeloma (RRMM) who have maintained a complete response for at least six months. This decision by the FDA provides an alternative to the standard weekly dosing, potentially easing the treatment burden for patients.
TECVAYLI®, a bispecific antibody targeting B-cell maturation antigen (BCMA) and CD3 on T-cells, was first approved in October 2022 for RRMM patients who have undergone at least four prior lines of therapy. The drug is designed to activate an immune response against multiple myeloma cells. Since its approval, over 3,600 patients in the U.S. have been prescribed TECVAYLI®.
The approval for the biweekly dosing is based on results from the Phase 1/2 MajesTEC-1 study, where patients initially received a weekly dose of 1.5 mg/kg. Those who achieved and sustained a complete response for six months or more were eligible to reduce the frequency of their doses to once every two weeks until disease progression or unacceptable toxicity.
Rachel Kobos, M.D., Vice President of Oncology Research & Development at Johnson & Johnson, stated that the approval for biweekly dosing will help clinicians tailor treatment schedules to the needs of individual patients. She emphasized TECVAYLI® as the only BCMA-targeted therapy with weight-based dosing.
The MajesTEC-1 study is a single-arm, open-label, multicohort, multicenter dose-escalation study that evaluated the safety and efficacy of teclistamab in adults with RRMM who had received three or more prior lines of therapy.
As with any treatment, TECVAYLI® comes with important safety information. It carries a warning for cytokine release syndrome (CRS) and neurologic toxicities, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), which can be severe or life-threatening. The drug is available only through a restricted program under the TECVAYLI® and TALVEY™ Risk Evaluation and Mitigation Strategy (REMS).
Multiple myeloma is a type of blood cancer that affects plasma cells in the bone marrow. Despite advances in treatment, it remains incurable, with a 5-year survival rate of approximately 59.8%. The approval of the biweekly dosing regimen for TECVAYLI® represents an ongoing effort to improve treatment options for those battling this disease.
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