Talquetamab

Talquetamab is a IgG4-PAA bispecific G protein-coupled receptor class C group 5 member D (GPRC5D)-directed CD3 T-cell engager. It consists of two arms - anti-GPRC5D and anti-CD3 arms - linked by two interchain disulfide bonds, each arm comprising a heavy and light chain. Talquetamab binds to GPRC5D, a cell surface receptor expressed predominantly on multiple myeloma cells, and CD3 on T cells. It works to recruit CD3-expressing T cells to GPRC5D-expressing multiple myeloma cells to induce T-cell–mediated cytotoxicity.

The Committee for Medicinal Products for Human Use (CHMP) of the EMA recommended conditional marketing authorization for talquetamab for the treatment of relapsed or refractory multiple myeloma on July 21, 2023. On August 9, 2023, talquetamab was granted FDA accelerated approval.

In the US, talquetamab is indicated for the treatment of adult patients 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. In Europe, talquetamab is indicated in patients who received at least three prior therapies and have demonstrated disease progression on the last therapy.

These indications are contingent, as talquetamab is only approved under accelerated approval in the US and conditional marketing authorization in Europe. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).