MIA's research pivotal in TGA's approval of new therapy
1 February 2016
Clinical research undertaken at Melanoma Institute Australia (MIA) has been pivotal in supporting the recent Therapeutic Goods Administration (TGA) approval of Opdivo (nivolumab) for advanced melanoma.
Australians welcome the news that Opdivo has been approved for use to treat advanced melanoma patients as a stand-alone treatment or in combination with Yervoy (ipilimumab). The combination of Opdivo and Yervoy for advanced melanoma is the first approval of its kind in Australia.
Opdivo, which is proven to improve survival, helps the body’s immune system to recognise and attack melanoma cells, which often masquerades as normal cells to avoid detection. Opdivo is a checkpoint inhibitor that blocks an immune-suppressing protein called PD-1. MIA, working with other leading melanoma researchers around the world, published two key studies that contributed to the approval of Opdivo by the TGA.
In one study, the research found that Opdivo improves overall survival among previously untreated patients who have advanced melanoma without a BRAF mutation.
The other study found that among previously untreated patients with metastatic melanoma, Opdivo alone or combined with Yervoy resulted in significantly longer survival than with Yervoy alone.
MIA’s Associate Professor Georgina Long, a lead research investigator for the studies, said: “It is great news to add another drug (an anti-PD-1 immunotherapy) to the armamentarium against melanoma; the next step is for consideration by the PBS for funding.”
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