Posted by Michael Wonder on 12 Jul 2018
Opdivo + Yervoy: first combination immunotherapy for advanced renal cell carcinoma (kidney cancer) receives TGA approval
11 July 2018 - Opdivo now approved in Australia for ten indications across six cancer types.
BMS today welcomed the TGA registration of Opdivo (nivolumab) 3 mg/kg in combination with another BMS immuno-oncology agent, Yervoy (ipilimumab), 1 mg/kg for the treatment of patients with intermediate/poor-risk, previously untreated advanced renal cell carcinoma.
This registration was granted under the new TGA priority review process that aims to expedite evaluation timeframes of new medicines and indications for serious conditions when there is substantial evidence of a major therapeutic advance.
The TGA approval was based on results of the clinical trial CheckMate-214 that showed Opdivo in combination with ipilimumab reduced the risk of death by 37% compared with sunitinib (HR=0.63 p<0.0001), in intermediate and poor-risk patients, meeting the co-primary end-point for overall survival.
