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Regeneron New
NEWS

Regeneron Reports the CHMP’s Positive Opinion for Adjuvant Libtayo to Treat High-Risk Cutaneous Squamous Cell Carcinoma (CSCC)

Shots: The CHMP has recommended Libtayo (cemiplimab) as an adj. treatment for CSCC adults who are at high risk for recurrence after surgery & radiation Opinion 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.; n=209) vs PBO (n=206) to treat…
October 21, 2025

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Regeneron New
NEWS

Regeneron Reports the US FDA’s Approval of Adjuvant Libtayo to Treat High-Risk Cutaneous Squamous Cell Carcinoma (CSCC)

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.…
October 9, 2025

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Regeneron New
NEWS

Regeneron Reports Interim Data from P-III (C-POST) Trial of Libtayo Adjuvant to Treat High-Risk Cutaneous Squamous Cell Carcinoma (CSCC)

Shots: The P-III (C-POST) trial assessed Libtayo adj. (n=205; 350mg, IV, Q3W for first 12wks. followed by 700mg, IV, Q6W for 36wks.) vs PBO (n=204) to treat high-risk CSCC patients (N=415) for ~48wks. Study met its first prespecified interim analysis, showing 68% reduced disease occurrence & death risk at 24mos. median follow-up, with additional…
January 15, 2025

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