Opdivo first anti-PD-1 therapy oked by TGA for adjuvant treatment of melanoma

Opdivo (nivolumab) has been registered by Australia’s Therapeutic Goods Administration (TGA) as an adjuvant treatment for patients with completely resected melanoma with involvement of lymph nodes or metastatic disease.

US pharma major Bristol-Myers Squibb’s (NYSE: BMY) Opdivo is the first immuno-oncology (I-O) 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 III 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 B-MS’ Yervoy (ipilimumab) (p<0.001). This latest TGA approval of Opdivo marks the ninth indication registered in Australia — and the third indication in melanoma — in under three years.