30 April 2018 - Opdivo now approved in Australia for nine indications across six cancer areas in under three years.

Bristol-Myers Squibb today announced that Opdivo (nivolumab) has been registered by theTGA as an adjuvant treatment for patients with completely resected melanoma with involvement of lymph nodes or metastatic disease.

OPDIVO is the first immuno-oncology therapy approved for a new indication under the TGA priority review pathway. This process shortens the evaluation timeframes for treatments in areas of high unmet clinical need where substantial benefit has been demonstrated.

The TGA approval of Opdivo was supported by the results from the global Phase 3 study CheckMate-238, which included Australian patients. The study demonstrated a reduction in the relative risk of disease recurrence or death by 35% compared to Yervoy (ipilimumab) (p<0.001).