Specifically, patients treated with Tecvayli must have received four or more prior lines of therapy, including a proteasome inhibitor, immunomodulatory drug and anti-CD38 monoclonal antibody.
The FDA’s decision is supported by evidence from the pivotal phase 2 MajesTEC-1 clinical trial in RRMM patients who had received a median of five prior lines of therapy.
An overall response rate of 61.8% was achieved in the study, notably with 28.2% of patients achieving a complete response or better, the company reported.
