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DewDiligence

09/18/20 10:43 AM

#949 RE: DewDiligence #927

CHMP approves Opdivo/Yervoy in 1L-NSCLC based on CHECKMATE-9LA study:

https://www.businesswire.com/news/home/20200918005259/en

The approved regimen is two cycles of standard chemotherapy followed by Opdivo + low-dose Yervoy (1mg/kg q6w) dosed for two years (or until disease progression). The approval is for all first-line NSCLC patients, regardless of PD-L1 expression or other histology.

The FDA approved this regimen in May 2020 (#msg-155857124).