Kevin Harrington, Professor in Biological Cancer Therapies at Institute of Cancer Research, shared on LinkedIn:
“With this post, I am pleased to highlight and post an Open Letter that has been sent to the FDA by the clinical trial investigators of RPL-001-16 (IGNYTE) and the members of the Steering Committee for IGNYTE-3 (the phase 3 trial that seeks to confirm the results of the IGNYTE study).
In this letter, we address two key criticisms levelled at the IGNYTE data by the FDA, namely heterogeneity of patient population and the agency’s uncertainty about the contribution of RP1 to the overall response rate, and we call on the FDA to revisit and reassess their decision. For those who wish to confirm the rigorous methodology applied in the IGNYTE study, I append here the link to the primary data presentation in the Journal of Clinical Oncology.
I am proud to add my name to this letter alongside clinicians who have made remarkable contributions to the development of new treatments for melanoma and other cancer types. Please share this information with your own network groups by reposting it, if you feel comfortable doing so.”
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