Ep 86: Tudriqev (RP1) FDA Approval

<p>In this episode, James and Sapna debate how to pronounce the newest FDA approved treatment for melanoma: T-U-D-R-I-Q-E-V</p><p>They discuss the FDA Cell and Gene Therapy Advisory Committee&#39;s review of the single-arm IGNYTE data and key issues around if this represents a local or systemic therapy, the maths around calculating response rate, and importantly how to identify optimal tumor characteristics for this treatment - what Sapna calls &quot;Larkin-izing&quot; the data.</p><p>It&#39;s a long episode with a short fact check and lots of shoutouts to Kevin Harrington for his work in this space. </p>