Bristol-Myers Squibb (NYSE:BMY) has withdrawn its
marketing application in Europe seeking approval to use the combination
of Opdivo (nivolumab) and Yervoy (ipilimumab) (O+Y) to treat advanced
non-small cell lung cancer in a first-line setting.
The company originally filed the application in
2018 based on the successful achievement of the co-primary endpoint of
progression-free survival (PFS) in patients with mutational burdens of
at least 10 mutations/megabase (CHECKMATE-227 study).
The application was later amended to include the
successful achievement overall survival (OS), the other co-primary
endpoint, in patients whose tumors expressed at least 1% PD-L1. These
participants received O+Y+chemo.
The European Medicines Agency determined that it
could not conduct a full assessment of the filing due to the multiple
protocol changes BMY made in response to rapidly evolving science and
data.
It has no plans to refile the application.
Its submission in the U.S. is currently under FDA review.
https://seekingalpha.com/news/3537043-bristol-myers-squibb-withdraws-european-application-for-o-y-for-lung-cancer
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