Dr. Garfall of the FDA Approval of Teclistamab in Relapsed/Refractory Multiple Myeloma

Alfred L. Garfall, MD, director, Autologous Hematopoietic Stem Cell Transplantation, Penn Medicine; assistant professor of Medicine, the Hospital of the University of Pennsylvania, discusses the significance of the FDA approval of teclistamab-cqyv (Tecvayli) in relapsed/refractory multiple myeloma and how this agent might fit into the treatment paradigm going forward.

On October 25, 2022, the FDA granted accelerated approval to teclistamab in adult patients with relapsed or refractory multiple myeloma who have received at least 4 prior lines of therapy, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent. The regulatory decision was based on findings from the phase 1/2 MajesTEC-1 trial (NCT03145181; NCT04557098), in which patients who received the agent achieved an objective response rate of 61.8%.

In accordance with its indication in the FDA approval, teclistamab will play a major role in the relapsed/refractory setting, as it can be administered quickly and has an excellent efficacy and safety profile, Garfall says. This agent may become the therapy of choice for patients in later lines of therapy treated at cancer centers in regions where CAR T-cell therapy is not readily available, and teclistamab will be easier for centers to use compared with the complexity of CAR T-cell therapy, Garfall notes.

Going forward, teclistamab may be placed in sequence among the other treatments that are currently available for later lines in multiple myeloma, including belantamab mafodotin-blmf (Blenrep), selinexor (Xpovio), and CAR T-cell therapies, Garfall explains. Future studies will also investigate this agent’s potential efficacy in earlier lines of treatment and in combination with other therapies to discern where it is most effective and whether it elicits the most benefit with other drugs or as monotherapy, Garfall concludes.