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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 H1’26Approval 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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Checkpoint Therapeutics
NEWS

Checkpoint Therapeutics’ Unloxcyt (Cosibelimab-ipdl) Receives the US FDA’s Approval for Cutaneous Squamous Cell Carcinoma (cSCC) 

Shots:   Checkpoint has received the US FDA’s approval for Unloxcyt (1,200mg, IV, over 60 minutes, Q3W) to treat metastatic or locally advanced cSCC in adults, ineligible for curative surgery or radiation Approval was based on the P-I (CK-301-101) trial in solid tumor patients (incl. cSCC: N=109), showing ORR of 48% with mDoR of 17.7mos. in…
December 13, 2024

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