Posted by Michael Wonder on 10 Aug 2023
FDA grants accelerated approval to talquetamab-tgvs for relapsed or refractory multiple myeloma
10 August 2023 - On 9 August 2023, the FDA granted accelerated approval to talquetamab-tgvs (Talvey, Janssen Biotech) 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.
Efficacy was evaluated in MMY1001 (MonumenTAL-1) a single-arm, open-label, multi-centre study that included 187 patients who had previously received at least four prior systemic therapies.
