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Clinical Trials: they are not designed only to be a “last resort”
Pancreatic Cancer | Last Active: Sep 13 7:47am | Replies (42)Comment receiving replies
I'm in a clinical trial at the NIH in Bethesda, MD for the drug Olaparib ( or Lynparza) for my acinar cell pancreatic cancer. Started early June and the drug has had a positive effect on the remaining CT visible tumor on my liver. I asked the Dr. in charge of the 2 yr. trial that if I continued to see progress until the end of the trial, and that if Olaparib had still not been approved by the FDA for acinar cell pancreatic cancer treatment, would I still be able to get the drug? The Dr. told me that she could write some type of letter to the VA, (I'm a disabled veteran), that would allow the VA to issue me the drug. So, as I understand your post, she would actually send the IP-IND letter the FDA on my behalf? I'm just trying to understand the process before I head back up the NIH on Sept. 24. Thank you for your time and any input.
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I was the first patient in the US on the RucaPANC trial conducted from 2014-2016 testing the biosimilar PARPi to Olaparib called Rucaparib (Rubraca). I have a germline BRCA2 mutation and acinar cell carcinoma. I was the longest person in the trial and when the trial was terminated, had a complete response from this PARPi. The Principal Investigator who conducted the trial wrote an “Individual Patient-Investigational New Drug” protocol and applied to the FDA to allow me to continue on the drug under “Compassionate Need”. The request was approved in less than 24 hours resulting in no interruption in dosing. The company that was developing the drug sought approval for ovarian and prostate cancers for which it was approved. With a small market for pancreatic and Astra Zeneca having the pancreatic cancer market, the company did not look to spend limited resources on pancreatic when their next targeted market was breast cancer.
The company declared bankruptcy and the rights to Rubraca was bought by a company based in Europe. The former company and now the new company has been providing the PARPi since the trial ended in April 2016. I have taken it since and is very well tolerated. October 10 will make 10 years on the drug.