FDA green light for Janssen Talvey in MM

The US Food and Drug Administration (FDA) has granted approval for Talvey (talquetamab-tgvs) for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

Talvey is under development at Janssen Biotech, a subsidiary of US healthcare giant Johnson & Johnson (NYSE: JNJ). Last month, the European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended the drug for approval.