Australia’s
Therapeutic Goods Administration (TGA) revealed today that it is
monitoring reports of melanoma in patients being treated with
natalizumab and encourages consumers and health professionals to report
all such cases.
Natalizumab (Biogen Idec’s [Nasdaq:
BIIB] blockbuster drug Tysabri, which generated global in-market sales
of $1.7 billion last year) is used to treat patients with
relapsing-remitting multiple sclerosis to delay the progression of
physical disability and reduce the frequency of relapse.
Melanoma is potentially
life-threatening and Australia has one of the highest incidence rates of
this condition in the world.Three cases of melanoma in patients being
treated with natalizumab have been reported to the TGA.
An ongoing TGA review of this issue has
found insufficient evidence to show a definite link between natalizumab
and melanoma. However, given the high incidence of melanoma in
Australia, this remains an issue of concern for the TGA.
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