TALVEY (Janssen-Cilag Pty Ltd)

TALVEY as monotherapy has provisional approval in Australia and is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma, who have previously received at least four prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody. The decision to approve this indication has been made on the basis of the overall response rate in a single arm study. Continued approval of this indication depends on verification and description of benefit in confirmatory trials.