Gilenya and...Cancer??

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Gilenya and...Cancer??

Postby Slumby » Sun Jan 16, 2011 3:52 pm

A neuro of mine has resisted prescribing Gilenya to me due to a risk of cancer. So far, I've found evidence of skin cancer occuring in 8 of the clinical trial subjects. I don't know how many subjects total there were and I don't remember where I read that (it was an internet search).

Has anyone else heard/read about Gilenya leading to cancer? Is my Dr. LYING to me?
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Re: Gilenya and...Cancer??

Postby NHE » Sun Jan 16, 2011 6:12 pm

Slumby wrote:A neuro of mine has resisted prescribing Gilenya to me due to a risk of cancer. So far, I've found evidence of skin cancer occuring in 8 of the clinical trial subjects. I don't know how many subjects total there were and I don't remember where I read that (it was an internet search).

Has anyone else heard/read about Gilenya leading to cancer? Is my Dr. LYING to me?


You may wish to have a read through the doctor's prescribing information sheet for Gilenya. It should have the information that you're after, size of trial groups, side effects, cancer risk, etc. However, since the medication is brand new, there may be risks associated with its use which aren't in the prescribing information yet.

http://www.pharma.us.novartis.com/produ ... ilenya.pdf

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Postby dignan » Sun Jan 16, 2011 6:14 pm

The report linked below, from Novartis to the FDA, includes as much info as I've found on gilenya and cancer. The relevant section starts on page 81, it is titled "6.4.5.7 Neoplasms". Then from later in the report there is this summary:

8.2.7 Malignancy
Pre-clinical data did not suggest an increased risk of malignancies with fingolimod, apart from lymphoma in mice at high doses. However, due to reports of skin malignancies during development, active screening was introduced in Phase 3. The incidence estimates for various forms of skin cancer (and indeed other malignancies) from pooled safety data are comparable between treatment groups and placebo with no evidence for a fingolimod dose-effect. These data, from up to 24-month treatment exposure, do not suggest a relationship of fingolimod therapy with the occurrence of cancer. However, the number of events to date and duration of follow-up is too limited to definitively exclude a relationship to low-incidence, late-occurring events. No specific monitoring is recommended in the label while on therapy although physicians should continue to report occurrences of malignancies with use of fingolimod therapy.



http://www.fda.gov/downloads/AdvisoryCo ... 214675.pdf
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Re: Gilenya and...Cancer??

Postby Athina » Sun Nov 20, 2011 8:41 am

I have heard of a link between Gilenya and skin cancer, too.

As for myself, neuros are unsure whether Gilenya could be an option or not. This is because I am a cancer survivor. Not skin cancer though.

Gilenya is an immunosuppressant, like many other drugs used to treat ms. Suppressing the immune system long-time increases the risk for cancer, so it's a double edged sword, really. On these grounds I was definitely denied Tysabri, we'll see what happens with the Gilenya option.
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