FDA approves new dose regimen for J&J multiple myeloma treatment
21 Feb 2024
Drug ApprovalAcquisitionImmunotherapy
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Source: Pharmaceutical Technology
J&J received approval for the Q2W dosing schedule based on data from the Phase I/II MajesTEC-1 clinical trial. Credit: Golden Shrimp / Shutterstock.com.
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.
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.
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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.
It 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.
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