FDA Approval Insights: Nirogacestat in Progressing Desmoid Tumors Requiring Systemic Treatment

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, sponsored by SpringWorks Therapeutics, we had the pleasure of speaking with Bernd Kasper, MD, PhD, about the FDA approval of nirogacestat (Ogsiveo) for patients with desmoid tumors. Dr Kasper is the chair of the Sarcoma Unit at the Interdisciplinary Tumor Center Mannheim at Mannheim University Medical Center at the University of Heidelberg in Germany.

On November 27, 2023, the FDA approved nirogacestat for the treatment of adult patients with progressing desmoid tumors requiring systemic treatment. This regulatory decision was backed by data from the phase 3 DeFi trial (NCT03785964), in which the median progression-free survival with the agent was not reached (NR; 95% CI, NR-NR) vs 15.1 months (95% CI, 8.4-NR) with placebo (HR, 0.29; 95% CI, 0.15-0.55; P < .001).

In our exclusive interview, Dr Kasper discussed the significance of this approval; key efficacy, safety, and quality-of-life outcomes from the DeFi trial; and findings from an analysis investigating tumor volume and T2 hyperintensity changes with nirogacestat in patients enrolled in DeFi that were presented at the 2023 ASCO Annual Meeting.

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That’s all we have for today! Thank you for listening to this episode of OncLive On Air, sponsored by SpringWorks Therapeutics. Check back on Mondays and Thursdays for exclusive interviews with leading experts in the oncology field.

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