Kevin Harrington, Professor in Biological Cancer Therapies at Institute of Cancer Research, shared on LinkedIn:
“There is a growing sense of incredulity around the FDA’s rejection of the Biologics License Application for Replimune’s oncolytic herpes simplex virus, RP1, in combination with Nivolumab for use in melanoma patients post anti-PD1 therapies.
Here, with his explicit permission, I share a letter sent by Professor Axel Hauschild, President of the Melanoma World Society, to the FDA Commissioner. As detailed in the letter, Professor Hauschild has unparalleled experience of treating malignant melanoma and states that the ‘IGNYTE trial showed the best efficacy/tolerability results of all second-line trials’ in his 35-year career.
Hopefully, the opinion of experts such as this will be taken into account as the FDA ponders its position.”
Other posts featuring Kevin Harrington.
