Ep 86: Tudriqev (RP1) FDA Approval

Ep 86: Tudriqev (RP1) FDA Approval

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

They discuss the FDA Cell and Gene Therapy Advisory Committee'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 "Larkin-izing" the data.

It's a long episode with a short fact check and lots of shoutouts to Kevin Harrington for his work in this space.

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