Australia’s TGA finds no definite link for natalizumab and melanoma

Since early last year, Australia’s Therapeutic Goods Administration (TGA) has been monitoring reports of melanoma in patients being treated with natalizumab and encouraged consumers and health professionals to report all such cases.

In a report issued today, the TGA says it has received only one further report of this adverse event relating to multiple sclerosis drug natalizumab, which is marketed as Tysabri by US biotech firm Biogen (Nasdaq: BIIB) and generated global sales of around $2 billion in 2014.

Analysis of the cases reported to the TGA, together with a review of Australian and international data, has found insufficient evidence of a definite link between natalizumab and melanoma. Based on this finding, the TGA is closing this issue in its Early Warning System.