FDA Approval Insights: Teclistamab in Relapsed/Refractory Multiple Myeloma

Welcome to OncLive On Air^®! I’m your host today, Ashling Wahner.

OncLive On Air^® is a podcast from OncLive^®, which provides oncology professionals with the resources and information they need to provide the best patient care. In both digital and print formats, OncLive^® covers every angle of oncology practice, from new technology to treatment advances to important regulatory decisions.

In today’s episode, we had the pleasure of speaking with Alfred L. Garfall, MD, the director of Autologous Hematopoietic Stem Cell Transplantation at Penn Medicine and an assistant professor of medicine at the Hospital of the University of Pennsylvania in Philadelphia. Dr Garfall joined us to talk about the FDA approval of teclistamab-cqyv (Tecvayli) in relapsed or refractory multiple myeloma.

On October 25, 2022, the FDA granted accelerated approval to teclistamab in heavily pretreated adult patients with relapsed or refractory multiple myeloma. The regulatory decision was backed by findings from the phase 1/2 MajesTEC-1 trial (NCT03145181; NCT04557098), in which the agent demonstrated an objective response rate of 61.8% and estimated 6-month and 9-month duration of response rates of 90.6% and 66.5%, respectively.

In our exclusive interview, Dr Garfall discussed the significance of this approval, key efficacy and safety data from MajesTEC-1, and how the drug’s unique mechanism of action lends to greater tolerability and accessibility compared with other anti-myeloma agents.

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