The European Commission (EC) has approved Janssen Pharmaceutical Companies of Johnson & Johnson’s Type II variation application for reduced dosing frequency of its bispecific antibody TECVAYLI (teclistamab) to treat multiple myeloma.
The approval allows patients who have achieved a complete response (CR) or better for at least six months to choose TECVAYLI’s reduced dosing frequency of 1.5mg/kg every two weeks.
Teclistamab, the first bispecific antibody directed at B-cell maturation antigen on multiple myeloma cells, and CD3 [a form of immunotherapy that enables soldier cells of the immune system to recognise and kill tumour tissue] on T-cells, both received approval in Europe to treat adults with relapsed and refractory multiple myeloma (RRMM).
Patients must have undergone a minimum of three prior therapies, including treatment with an immunomodulatory agent, an anti-CD38 antibody and a proteasome inhibitor.
They should also have shown disease progression during their most recent therapy.
The latest approval from the EC was supported by positive outcomes from the Phase I/II MajesTEC-1 trial, which assessed teclistamab's safety and efficacy in RRMM patients.
Patients who showed a confirmed partial response (PR) or better after four or more treatment cycles in Phase I, or a confirmed CR or better lasting at least six months in Phase II, were eligible to switch to a reduced dosing frequency subcutaneously every two weeks.
The new dosing regimen was then maintained until there was disease progression or unacceptable toxicity.
Janssen Clinical Research and Development vice-president Sen Zhuang stated: “When advancing immune-based therapies such as teclistamab, tailored approaches are essential to allow us to respond to evolving data and evidence to find the most suitable balance of efficacy and safety.
“Today’s approval reinforces our focus on strengthening our multiple myeloma portfolio by investing in cutting-edge research that will help us continue to improve patient outcomes and importantly, their quality of life.”
