FDA Greenlights Reduced Dosing Frequency for Johnson & Johnson’s TECVAYLI

Johnson & Johnson

HORSHAM, PA — Johnson & Johnson recently announced that the U.S. Food and Drug Administration (FDA) has granted approval for a reduced dosage frequency of its drug TECVAYLI® (teclistamab-cqyv) in specific patient cases. This decision paves the way for increased flexibility in treatment plans for patients with relapsed or refractory multiple myeloma (RRMM), a rare form of cancer that affects plasma cells.

TECVAYLI® is a bispecific antibody, a type of drug that can attach to two different types of proteins at once. In this case, it targets B-cell maturation antigen (BCMA), found on multiple myeloma cells, and CD3 on T-cells, a type of immune cell. This dual action helps to rally an immune response against the cancer cells.

The FDA’s recent approval allows for a reduced dosing regimen of 1.5 mg/kg every two weeks for patients who have achieved and maintained a complete response (CR) – no signs of cancer after treatment – or better for at least six months. This offers a more manageable treatment schedule for those patients who are responding well to the drug.

Since its initial approval in October 2022, TECVAYLI® has been prescribed to over 3,600 patients in the U.S. It was initially approved for patients with RRMM who had undergone at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody.

This latest approval by the FDA is based on results from the Phase 1/2 MajesTEC-1 study, which tested the efficacy and safety of TECVAYLI®. Patients who responded positively to the drug for six months or longer were eligible to reduce their dosing frequency until disease progression or unacceptable toxicity.

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“TECVAYLI is the only BCMA-targeted immune-based therapy with weight-based dosing,” said Rachel Kobos, M.D., Vice President, Oncology Research & Development, Johnson & Johnson Innovative Medicine. “[The] approval of biweekly dosing for eligible patients will further enable clinicians to meet the individual needs of patients who may want flexibility in their dosing schedules.”

As the first bispecific approved for the treatment of this disease, TECVAYLI® continues to set the pace in the market, offering hope to those battling this challenging form of cancer.

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