The US Food and Drug Administration (FDA – the medicines regulator in the US) has granted approval to a “supplemental biologics license application” for teclistamab-cqvy (Tecvayli®). This means the existing FDA teclistamab license has been extended to include administration at a reduced dosing frequency of 1.5 mg/kg every two weeks, instead of once weekly (as is currently the case) for patients with relapsed/refractory myeloma who have maintained a sustained complete response (CR – a very deep response to treatment) or better for at least 6 months.

Teclistamab-cqvy is administered subcutaneously. It is currently approved in the US for the treatment of adult patients with relapsed and refractory myeloma who received at least four prior lines of therapy, including a proteasome inhibitor (such as bortezomib), an immunomodulatory drug (such as lenalidomide), and an anti-CD38 monoclonal antibody (such as daratumumab).

The dose reduction is aimed to improve quality of life of patients by allowing patients fewer visits to the hospital, whilst at the same time maintaining their response to treatment. It is also aimed to reduce the potential risk of side effects from teclistamab, including infections.

The FDA’s decision is based on data from the phase I-II MajesTEC-1 clinical trial, where relapsed/refractory patients who had received at least three prior lines of therapy, initially received teclistamab at the recommended phase II dose of 1.5 mg/kg every week. Patients achieving a sustained CR or better for 6 or more months were eligible for a reduced dose of 1.5 mg/kg every 2 weeks. The results of the trial highlighted that despite the dose reduction, patients were able to maintain their response to treatment and had a sustained remission.

Does this apply in Europe?

The European Medicines Agency (EMA – the medicines licensing body in Europe) has granted for teclistamab for relapsed and refractory myeloma patients who have received at least three previous treatments (slightly different to the FDA approval), including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody. They have yet to issue guidance on the amended dosing schedule, but MPE will monitor the situation and update our members in due course.

Further information

For further information on teclistamab, you can read the MPE teclistamab factsheet here.

Read the full press release here.