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Nanoknife for pancreatic cancer
Pancreatic Cancer | Last Active: Nov 7 3:53pm | Replies (46)Comment receiving replies
Thank you gracect. That’s certainly disappointing. Offering info on new drugs is not my forte. I only saw that it looks like FDA is approving it for some uses but not for pancreatic cancer. I would pose the question to @stageivsurvivor to see if he has any suggestions on how one might try and proceed to see medication could be approved ; or if there is something similar to it that’s already been approved? Praying for good results for you.
Replies to "Thank you gracect. That’s certainly disappointing. Offering info on new drugs is not my forte. I..."
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If an investigational new drug that was part of a trial showed evidence that it proved efficacious as determined likely by the RECIST version 1.1 guidelines which is a common measurement standard for tumors and the trial ended or was terminated, the principal investigator of the trial can write an Individual Patient Investigational New Drug application and submit to the FDA for approval on compassionate need. This is what was done in my case when the trial was terminated and it was shown I had a complete response to the trial drug. The FDA acted on the application within 24 hours and I was allowed to continue receiving the drug under compassionate use. The manufacturer agreed to continue supplying the drug and I continue to be closely monitored 8.5 years after the trial was terminated.