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.

This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication is contingent upon verification and description of clinical benefit in confirmatory trial(s).