Janssen’s Tecvayli granted FDA approval for multiple myeloma
Janssen – a pharmaceutical arm of Johnson & Johnson – has announced that Tecvayli (teclistamab-cqyv) has been approved by the US Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM).
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.
The median time to first response was 1.2 months and, with a median follow-up of 7.4 months, the estimated duration of response rate was 90.6% at six months and 66.5% at nine months.
Read more: https://www.pmlive.com/pharma_news/janssens_tecvayli_granted_fda_approval_for_multiple_myeloma_1479795
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.
The median time to first response was 1.2 months and, with a median follow-up of 7.4 months, the estimated duration of response rate was 90.6% at six months and 66.5% at nine months.
Read more: https://www.pmlive.com/pharma_news/janssens_tecvayli_granted_fda_approval_for_multiple_myeloma_1479795
