By Blood Cancers Today Staff Writers - Last Updated: February 20, 2024
The US Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for teclistamab (TECVAYLI®) for biweekly dosing in patients with relapsed or refractory multiple myeloma (MM) who have achieved and maintained a complete response (CR) or better for a minimum of six months, according to a press release from Johnson & Johnson, the manufacturer of the drug.
The sBLA was approved for a reduced dosing frequency of 1.5 mg/kg every two weeks in this group of patients and is based on results from the phase I/II MajesTEC-1 study, a single-arm, open-label, multicohort, multicenter dose-escalation study to evaluate the safety and efficacy of teclistamab in adults with relapsed or refractory MM who received three or more prior lines of therapy.
In the trial, a total of 165 patients received the recommended phase II dose of 1.5 mg/kg once weekly. Participants could switch to once every other week dosing if they achieved a confirmed partial response (PR) or better after four or more cycles of treatment in phase I, or a confirmed CR or better for six or more months in phase II.
During an abstract presentation at JADPRO Live in Orlando in 2023, the authors noted that “a less frequent dosing schedule offers added convenience and flexibility to patients, physicians, and caregivers.”
Original Source: FDA Approves SBLA for Teclistamab in Relapsed or Refractory Myeloma | Blood Cancers Today