Friday, May 16

Australian regulator finds no definite melanoma link for Tysabri/natalizumab

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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