The US regulator approved the company’s supplemental Biologics License Application (sBLA) for the reduced, bi-weekly dosing of Tecvayli in patients with relapsed or refractory multiple myeloma (RRMM) who have achieved complete response (CR)
US FDA approves biweekly dosing of Tecvayli in patients with RRMM. (Credit: Myriams-Fotos from Pixabay)
Johnson & Johnson (J&J) has received the US Food and Drug Administration (FDA) approval for Tecvayli (teclistamab-cqyv) for a reduced dosing frequency of 1.5 mg/kg every two weeks.
The drug is indicated in patients with relapsed or refractory multiple myeloma (RRMM) who have achieved and maintained a complete response (CR) for at least six months.
Tecvayli is the first bispecific antibody targeting B-cell maturation antigen (BCMA) on multiple myeloma cells and CD3 on T-cells to activate an immune response.
The drug is already approved in the US, under accelerated approval, for the treatment of adults with RRMM who received at least four prior lines of therapy.
Currently, the US regulator approved the company’s supplemental Biologics License Application (sBLA) for the reduced, bi-weekly dosing of Tecvayli.
According to J&J, there is a continued unmet need for patients with multiple myeloma and the FDA approval allows increased flexibility in the dosing for patients with a weight-based regimen.
Johnson & Johnson Innovative Medicine oncology research and development vice president Rachel Kobos said: “Tecvayli is the only BCMA-targeted immune-based therapy with weight-based dosing.
“Today’s 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 FDA approval is based on results from Phase 1/2 MajesTEC-1 study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of teclistamab.
The Phase 1 study was conducted in two parts, dose escalation and dose expansion.
The Phase 2 study evaluated the efficacy of teclistamab at the recommended Phase 2 dose (RP2D) of 1.5 mg/kg Tecvayli weekly, administered subcutaneously, as measured by ORR.
Patients who achieved a confirmed CR for six months or longer were eligible for a reduced dosing frequency of bi-weekly 1.5 mg/kg until disease progression or unacceptable toxicity.
In August 2022, Tecvayli received the European Commission (EC) conditional marketing authorisation to treat adult patients with RRMM who received at least three prior therapies.
In August last year, the EC approved a Type II variation application for Tecvayli, allowing a reduced dosing frequency of 1.5 mg/kg every two weeks.