The US Food and Drug Administration (FDA) has granted authorization for a biweekly dosing regimen of Johnson & Johnson’s (J&J; NYSE: JNJ) bispecific T-cell engager (BiTE) Tecvayli (teclistamab). Tecvayli received accelerated approval in 2022 for the treatment of relapsed or refractory multiple myeloma (r/rMM) in patients who have undergone at least four prior lines of therapy. This new dosing regimen is designed for patients who have achieved and sustained a complete response (CR) or better for a minimum of 6 months.
The FDA’s decision to approve the reduced frequency scheme comes after a review of safety and pharmacokinetics data from a Phase I/II study that evaluated alternative dosing schedules of the subcutaneous injection. This regulatory update could offer patients a more convenient treatment option while maintaining the drug’s efficacy.
The authorization of the biweekly dosing regimen for Tecvayli highlights J&J’s commitment to improving treatment options for patients with multiple myeloma and underscores the FDA’s support for innovative dosing strategies that can enhance patient care.- Flcube.com
