The CAL-101/GS1101/Idelalisib Journey: Nov 2013 Update

It's been a while since I've had anything to report on John or Marian's status other than normal test results. And I don't have anything major to report now, but there are a couple of things I want to share for the benefit of other CLL patients following this drug and waiting to hear when it is expected to receive FDA approval.

First, we have been advised by a couple of sources that approval for Idelalisib (formerly known as CAL-101 and GS1101) is expected in February 2014. That is such good news for those of you who are patiently waiting for this drug to be available to all. John and Marian are going to be interviewed in the near future for some kind of media report that is now in the works. I don't have a lot of information, but Dr. Flinn asked if he could pass along their names to the person conducting the interviews, and they were both more than happy to share their success stories. I will post more information when I know whether this will be a phone interview (for print) or something else. They signed a media release at their appointments Monday and are waiting to be contacted.

I have kept an Excel Spreadsheet on both John and Marian since their initial diagnosis. Every change in their test results, every change in treatment, etc. is documented and at my fingertips on the computer. As we have been on cruise control for quite a while now, I sometimes let the lab reports stack up (always in a place I can quickly put my hands on them) and forget to enter the numbers. This was something I did immediately after each doctor visit in the earlier days of this journey. Since our eight week checkups have become so routine, though, I have occasionally wondered why I continue to log every blood result. But I've been doing it since 2007 for John and 2008 for Marian, so I'm not likely to ever stop recording these numbers. And it is helpful to be able to go back and see trends once you realize one has been forming. It also helps to have other notes on these spreadsheets to refer back to.

I just finished updating both of their charts and realized that John has been on one dose per day for over a year. Some of you may remember that he is the only patient in trial who responded to 50 mg. 2x daily. And when they stopped making a 50 mg. capsule, John went to a single dose daily of 100 mg. It seems like that happened a few months ago, but I was reminded by my spreadsheet that it was July 2012!

There is no change in Marian's status. She remains in remission and is feeling good. She had a few enlarged nodes several months back and we were a little concerned, but they remained stable on the next ct scan. And Dr. Flinn always reminds us that waxing and waning is part of the territory for CLL. He looks for trends and when a trend develops over time, we address it and consider adjustments in treatment.

John also continues to do well, but his lymphocytes have been creeping upward ever so slightly (but consistently). It's interesting to me that his lymphocytes started to inch upward not long after going to that single dose. It could be that keeping the drug in the bloodstream by breaking up the dose is helpful. And studying patients is the way these things are learned. His numbers are not anything to be concerned about. His white count is 9. But last November his ALC was 2.2 and this November his ALC is 5.4 (normal is 0.85 - 4.1). John's was 3.9 in June. That's the last time he was within the normal range. Every eight weeks there is a slight increase. We have been watching it and wondering. And at our visit Monday, Dr. Flinn recommended increasing John's dose of Idelalisib. After consulting the drug company that produces Idelalisib, John's dosage was changed from 100 mg. once per day to 100 mg. 2x per day. Hopefully when we go back in January, those lymphocytes will be down.

I'm amazed that John has been stable on such a low dose for 3.5 years. I believe the standard therapeutic dose is or is going to be 150 mg. twice a day. So he has more wiggle room to go up if he needs to. And if the day comes when Idelalisib is not as effective for him, we have other Kinase Inhibitors as options. I'm so thankful chemo is no longer the best option for fighting CLL! And I'm thankful that many of you reading this are even closer to having access to these drugs.

We won't see Dr. Flinn again until mid-January, but I will definitely post an update of lab results after our next checkup! And I'll let you know about the interview.


Anonymous said…
Brilliant progress! Thank you for posting this info.

From my limited knowledge, ibrutinib makes some irreversible changes to your cells whereas idelalisib does not seem to be permanent and if true, would be the least invasive. If idelalisib and ibrutinib are ultimately determined to be temporary albeit lasting therapies, it seems as if idelalisib would be the least hurtful to your longer run health?