Posted by Michael Wonder on 31 Mar 2020
TGA publishes another AusPAR for Opdivo (nivolumab)
31 March 2020 - First apparent TGA rejection for nivolumab.
The AusPAR describes the application by BMS to register Opdivo (nivolumab) for the following indication for use as monotherapy for the treatment of adult patients with advanced or recurrent gastric or gastro-oesophageal junction cancer after two or more prior systemic therapies.
The application was supported by a Phase III clinical trial (Study ONO-4538-12 or ATTRACTION-2).
The Advisory Committee on Medicines advised that due to design limitations, the evidence provided by the ATTRACTION-2 trial supports a marginal benefit-risk profile of nivolumab for use in 3+L gastric adenocarcinoma in patients with an ECOG performance status of 0 or 1.
The Delegate was not satisfied that efficacy and safety of the product has been satisfactorily established for the purpose for which it was proposed to be used.
