Shots:
- The US FDA has approved Libtayo (cemiplimab-rwlc) under priority review as an adj. treatment for CSCC adults who are at high risk for recurrence after surgery & radiation; application under EMA’s review, with decision expected in H1’26
- Approval was based on the P-III (C-POST) trial assessing Libtayo adj. (350mg, IV, Q3W for first 12wks. followed by 700mg, IV, Q6W for 36wks.) vs PBO to treat high-risk CSCC pts (N=415) for ~48wks.
- Trial showed 68% reduced disease occurrence & death risk, with favorable safety; data was published in The NEJM& presented at ASCO’25
Ref: Regeneron | Image: Regeneron | Press Release
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