Sunday, February 6, 2011

FDA approval of Ipilimumab

Meagan is on week 14 of her Ipilimumab treatment.  This is a biological treatment, not a chemotherapy, and one of the most promising developments in the treatment of metastatic melanoma. The treatment consisted of 4 infusions of the drug every three weeks, with a scan at the start, a scan at week 12, and one scheduled for week 16. Ipilimumab has not yet been approved by the FDA. That is scheduled for March 26, 2011. She is not part of the clinical trial, although the cost of the treatment is being covered by the sponsoring drug company. She is on what as known as compassionate use status.  It's that period in between conclusion of the clinical trials and before approval by FDA (looking at safety data and success rates).  They still use the data gathered by patients on compassionate use for safety and efficacy.

One of the things that's apparent is there may be a difference in expected outcomes versus forecast outcomes. The drug company (Bristol Meyers Squibb) is providing data to the FDA based upon 12 week scan outcomes.  But I've seen a presentation from an oncologist at Sloan Kettering in which many (positive) outcomes  occur in between week 12 and week 16.  This is obviously what we are rooting for in that Meagan did not show any shrinkage in tumors at the week 12 scan versus the initial scan, and had some small subcutaneous tumors emerge. After the week 12 scan she went on Tamoxifin and Lupron to shut down her estrogen hormone system under the hypothesis that there is a link for her between that and the melanoma.
What we are hoping for is a positive response for her to the Ipilimumab between week 12-16, so she can do another round in the near term.  We also want FDA approval ASAP so our oncologist can prescribe it freely (instead of having some discretion lay with the drug company).  We may not know if it's the drug or the lack of hormones that causes the positive response by week 16, but who cares, as long as it's working!

Meagan had very few side effects from the drug - a bit of fatigue and mostly some all over, persistent itching, which continues to this day.  We think that's a positive sign that her immune system is kicking into gear.  Ipilimumab tries to activate your body's own immune system to recognize the cancer and train it to go after it. Chemotherapy is ineffective against melanoma. For some reason melanoma is able to hide from your body's immune system, and this drug activates the T-cells in your body to go into attack mode. Unfortunately sometimes it doesn't discriminate between cancer cells and healthy cells, so there can be severe side effects, typically in about 25% of people.  They can treat and manage these side effects, usually.  They used to give a higher dose of the Ipilimumab, 10mg per kilo of body weight, but it's now at 3mg per kilo.  Unlikke chemotherapy there is no hair loss!

Our oncologist has been great about figuring out how to finesse getting her on to Ipilimumab.  He and the clinical research nurse are also looking into other clinical trials that Meagan might be eligible for if the Ipilimumab and anti-hormones don't work.  First she will probably have to go through a treatment of Interleukin-2, the only FDA approved biological therapy.  That is a two week hospital stay for treatment.  The thing about clinical trials is that you want to get in a non-randomized trial, where you know you are getting the treatment.  It's also called an open label treatment.

At each stage we hope for success.  We are also looking down the road and with our oncologists support understanding Plans, B, C, D, and E. The goal is to eliminate the disease, or get it under control while the science catches up.  In the meantime there is the wait between scans and treatments - and doing all the things under our control - like healthy eating and exercise and the right cancer fighting supplements.

No comments:

Post a Comment