The US Food and Drug Administration (FDA) has approved Johnson & Johnson¡¯s (J&J) supplemental biologics licence application for TECVAYLI (teclistamab-cqyv), allowing for a reduced dosing frequency for relapsed or refractory multiple myeloma (r/r MM) patients.
The newly approved regimen permits dosing with 1.5mg/kg TECVAYLI every two weeks (Q2W schedule) for patients who have had or maintained a complete response for a minimum of six months.
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TECVAYLI is a subcutaneous bispecific antibody that acts on both B-cell maturation antigen (BCMA) on multiple myeloma cells and clusters of differentiation 3 (CD3) on T-cells. This approach triggers an immune response.
The therapy was initially approved in October 2022 for r/r MM patients who had undergone a minimum of four previous lines of therapy.
The latest approval for the Q2W dosing schedule is based on data from the Phase I/II MajesTEC-1 clinical trial.
The open-label, single-arm, multicohort, multicentre dose-escalation trial involved adult r/r MM patients who had previously received three or more lines of therapy.
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By GlobalDataIt initially treated patients with a weekly dose of 1.5mg/kg of TECVAYLI. Those who achieved a confirmed complete response or better for six months or more could reduce their dosing frequency to 1.5mg/kg Q2W.
J&J innovative medicine oncology research and development vice-president Rachel Kobos stated: ¡°TECVAYLI is the only BCMA-targeted immune-based therapy with weight-based dosing. 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 multiple myeloma, combined with the longest in-market experience by physicians, TECVAYLI is another example of our commitment to pioneering cutting-edge research to help improve outcomes for patients with multiple myeloma.¡±
The latest development comes after the company signed a definitive agreement to acquire Ambrx Biopharma in a $2bn cash deal.
