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?
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.
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