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DewDiligence

09/20/21 9:23 AM

#1027 RE: DewDiligence #1009

FDC of Opdivo/Relatimab—(anti-LAG-3)—has 3/19/22 PDUFA date for 1L-melanoma (with FDA priority review):

https://finance.yahoo.com/news/u-food-drug-administration-accepts-105900488.html
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DewDiligence

03/19/22 1:39 PM

#1067 RE: DewDiligence #1009

FDA approves Opdualag—a_co-formulated_FDC_of Opdivo and anti-LAG-3 relatlimab—in first-line melanoma:

https://www.businesswire.com/news/home/20220304005561/en

The approval is based on the RELATIVITY-047 trial, which tested Opdivo + relatlimab against Opdivo monotherapy and had a PFS HR=0.75 (#msg-163914232).

In first-line melanoma, Opdulag offers comparable efficacy to Opdivo + Yervoy with less toxicity.

My abbreviated take:
https://twitter.com/DewDiligence/status/1395141087413538822