Posted by Michael Wonder on 11 May 2021
BMS withdraws application for Opdivo/Yervoy combination
11 May 2021 - Details revealed in new AusPAR.
BMS has withdrawn its application for nivolumab (Opdivo) for use in combination with ipilimumab for the first-line treatment of patients with metastatic non-small cell lung cancer who have tumour mutational burden ≥ 10 mutations per megabase with no known EGFR or ALK positive tumour mutations.
The application was withdrawn on 24 December 2020 in the light of the TGA's concerns about the design and conduct of the pivotal Phase 3 clinical trial (CheckMate-227).
The corresponding application for ipilumumab (Yervoy/Winglore) was also withdrawn on 24 December 2020.
