John Judd urges FDA to reverse Replimune RP1 melanoma denial
Updated
Updated · The Wall Street Journal · May 8
John Judd urges FDA to reverse Replimune RP1 melanoma denial
14 articles · Updated · The Wall Street Journal · May 8
Writing from Thurlaston, England, Judd said Replimune's RP3 trial in 2022 restored 95% function in his arm within six months after sarcoma treatment had failed.
He said surgery, radiotherapy and chemotherapy had left him facing likely amputation, but the two-year trial healed four visible tumours and possibly saved his life.
In a Wall Street Journal letter responding to an April 22 editorial, Judd called it a travesty that melanoma patients are denied RP1 when existing treatments have proved ineffective.
After a similar drug saved his life, why is the FDA denying a promising melanoma therapy to patients who have run out of options?
With the FDA now favoring single-trial approvals, why was a breakthrough melanoma drug with impressive data rejected twice over its trial design?