BMS withdraws its US marketing approval for Opdivo as second line treatment of liver cancer
BMS has withdrawn its immunotherapy Opdivo in liver cancer three months after FDA advisory panel recommended not to uphold the drug's 2017 approval in that indication. FDA granted Opdivo monotherapy an accelerated clearance in second-line liver cancer based on a Phase 2 study showing a minority of patients responded to treatment. But BMS wasn't able to confirm, in further testing, that Opdivo helped patients live longer, and other immunotherapies have since proven effective against the disease, leading panelists to vote in April against the drug's continued use.
The withdrawal doesn't impact use of Opdivo in combination with BMS’ other immunotherapy, Yervoy, in the same setting in liver cancer, or as a monotherapy in any other indication. But it is the latest result from an ongoing push by U.S. regulators to pull accelerated cancer drug approvals that lack confirmatory data.
Opdivo and Yervoy combination falls short in first-line squamous head and neck cancer
Bristol Myers Squibb’s phase 3 trial measuring the efficacy and safety of Opdivo and Yervoy in platinum-eligible patients with recurrent or metastatic SCCHC. In the study, pitting the drugs against the Extreme treatment regimen in first-line SCCHC, Opdivo and Yervoy failed to show a significant statistical edge. Although Opdivo plus Yervoy showed a clear, positive trend towards OS in patients whose tumors express PD-L1 with a combined positive score (CPS) ≥ 20, the study did not meet its primary endpoints.
The safety profile of Opdivo and Yervoy in this trial was consistent with previously reported studies in solid tumors. Opdivo monotherapy previously demonstrated a survival benefit in adults with recurrent or metastatic SCCHN after platinum-based therapy in the CheckMate -141 trial. Based on these results, the FDA and EMA approved Opdivo for this indication in 2016.