FDA Approval Insights: Nadofaragene Firadenovec in BCG-Unresponsive NMIBC

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Dr Shore discusses the FDA approval of nadofaragene firadenovec in non–muscle invasive bladder cancer, the benefits of this therapy’s administration method and schedule, and how this agent’s efficacy and safety pave the way for future treatment advances.

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 Neal Shore, MD, FACS, the US chief medical officer of Surgery and Oncology at GenesisCare USA and the medical director at Carolina Urologic Research Center in Myrtle Beach, South Carolina. Dr Shore joined us to talk about the FDA approval of nadofaragene firadenovec-vncg (Adstiladrin) in non–muscle invasive bladder cancer (NMIBC).

On December 16, 2022, the FDA approved the intravesical therapy nadofaragene firadenovec for adult patients with high-risk Bacillus Calmette-Guérin–unresponsive NMIBC with carcinoma in situ (CIS) with or without papillary tumors. This regulatory decision was backed by findings from the phase 3 Study CS-003 (NCT02773849), in which the agent demonstrated a complete response rate of 51% within the first 3 months of treatment in patients with CIS with or without high-grade Ta or T1 disease.

In our exclusive interview, Dr Shore discussed the significance of this approval within the context of the current NMIBC treatment paradigm, the benefits of this therapy’s administration method and schedule, and how this agent’s favorable efficacy and safety profile paves the way for future advances in NMIBC.


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