Update: Ibrutinib has just been approved by the FDA for CLL, which should make it widely available to CLL and Richter's patients.
I have been on Ibrutinib for just six days now -- 420 mg daily -- and the effect has been nothing short of extraordinary. An abdominal lymph node mass that I keep track of has shrunk considerably and I have lost 14 pounds, most of it edema caused by the swollen nodes blocking things up. My belly has gone from looking about seven months pregnant to about three.
This good response is particularly welcome since Ibrutinib was my last, best hope in terms of therapy to reduce and control my post-Richter's aggressive lymphoma, DLBCL. The smaller the tumor burden when it comes time for transplant conditioning, the better. And if I can enter the transplant with nodes under 5 cm, my chances of success are greatly improved.
As you may know, Ibrutinib has shown excellent results in clinical trials in both CLL and DLBCL. It's not approved by the FDA for either disease yet, but when it is approved it will no doubt be a game-changer.
But what if you need it now?
As a public service, let me tell you a little bit about my experience of not getting Ibrutinib, and then getting it. It comes down to standard of care -- your local oncologist may lack the wherewithal to get the job done, while a doctor at an institution that provides better care may have a better idea of how the system works and how to get the drug.
Ibrutinib (now also known as Imbruvica) was approved in November by the FDA for Mantle Cell Lymphoma, making it more widely available, including for "off-label" use. I had assumed that one needed to get into a clinical trial to get Ibrutinib. Dr. Droll, my local oncologist, thought maybe I could qualify for compassionate use of the drug. He assigned the task of inquiring to a research nurse in his office, and nothing happened. (He is part of a mid-level, multi-doctor practice, so it's not podunk, but not adequate to the task, either.) He was reticent to pursue off-label use, and my guess is this may have had something to do with the liability policies of his practice.
Meanwhile, January 1 rolled around and, thanks to the Affordable Care Act, I was able to get much-improved insurance through Blue Cross. On January 7, I went in for a transplant consultation with Dr. Jose Leis at the Mayo Clinic in Phoenix. Dr, Leis also thought Ibrutinib might be my best option. How do I get my hands on it?, I inquired.
Dr. Leis simply wrote a prescription. Ibrutinib is available at a small number of specialty pharmacies. Back when I took Revlimid, I dealt with one of those -- Biologics, a specialty pharmacy in North Carolina. They would send me a new supply of Revlimid via FedEx once a month.
Well, Ibrutinib is handled in a similar way. In this case, the prescription went to another specialty pharmacy, Avella, which then contacted Blue Cross for approval. The helpful lady at the pharmacy explained that other patients in my situation had all been approved by my insurance, and after about four business days, I was, too. Et voila, a bottle of Ibrutinib was sent to me via FedEx.
No fuss, no muss, and it took about three weeks from the time Dr. Leis wrote the prescription. If you could truly benefit from Ibrutinib and your doctor is telling you it is impossible or nearly impossible to get, that's just not the case.
One of the great benefits of my new insurance is being able to have access to a higher standard of care. For a patient in a tricky situation, such as myself, this makes an important difference. Dealing with a doctor and a staff who are on top of things, who haven't missed a beat, is a great relief.
5 Years Since I started on Ibrutinib for my CLL (chronic lymphocytic leukemia) in a Phase 1 Clinical Trial at Ohio State - May 5, 2017 marked 5 years since I swallowed my first 3 capsules of PCI-32765, now better known as ibrutinib or Imbruvica. I still take 3 battleship grey ca...
4 days ago