FDA hands Bristol Myers a landmark approval in early-stage lung cancer after just five days
On Feb. 28, the FDA accepted Bristol Myers Squibb’s application for approval of a new use of blockbuster checkpoint inhibitor Opdivo and said it would make a decision by July 13.
That estimate turned out to be conservative, to say the least. On Friday, just five days after accepting the application, the FDA OK’d it, handing the Big Pharma a landmark approval.
Opdivo can now be used to treat patients with early-stage non-small cell lung cancer prior to receiving surgery to remove their tumor. Although Opdivo and other PD-(L)1 inhibitors have already transformed treatment for more advanced forms of the disease, improving survival by replacing or supplementing toxic chemotherapy with more tolerable and effective molecules that take the “brakes” off the immune system, the drugs have yet to reach many of the earliest stage patients.
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