Bristol Myers Opdivo combo gets FDA nod for expanded use in lung cancer

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• The U.S. Food and Drug Administration (FDA) approved Bristol Myers Squibb's (NYSE:BMY) Opdivo (nivolumab) in combination with platinum-doublet chemotherapy for adult patients with resectable non-small cell lung cancer (NSCLC) in the neoadjuvant setting (use before surgery).
• The company said the approval marks the first-and-only immunotherapy-based treatment for use before surgery for non-small cell lung cancer. Opdivo plus chemotherapy is approved regardless of PD-L1 status.
• The company said Opdivo-based combinations now approved in both metastatic and earlier stages of non-small cell lung cancer.
• The approval was backed by data from the phase 3 trial, dubbed CheckMate -816, which showed that the drug combination improved event-free survival and pathologic complete response compared to platinum-doublet chemotherapy alone.

Comments

[Seeking ROI]

Announcements about new or expanded FDA approvals should include some indication of potential market size to be truly useful in evaluating significance. This is on the pharma companies to provide.

[miragesfz]

unless this is a sub-population that the FDA approved, which I dont think it is as it clearly says resectable, this may be the fastest approval ever. Just last week they issued a PR on the PDUFA date being approved with priority review of July 13th. So they filed, Jan 13th? If thats the case a Jan 13th filing with a March 4th approval is less than 2 months. Wow.