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- FDA Approves Cemiplimab as First, Only Adjuvant Immunotherapy . . .
Cemiplimab is the first immunotherapy approved for adjuvant treatment in CSCC, offering a new option for patients at high risk of recurrence
- label - Food and Drug Administration
During the treatment period ranging from 8 to 19 months in 5 clinical studies, the incidence of anti-cemiplimab-rwlc antibodies in LIBTAYO-treated patients was 2% (22 1029)
- FDA Approves Libtayo for Immunotherapy for Adjuvant Treatment . . .
FDA approved of Regeneron Pharmaceutical’s Libtayo (cemiplimab-rwlc)as an adjuvant treatment for adult patients with cutaneous squamous cell carcinoma (CSCC) who are at an increased risk of recurrence following surgery and radiation 1 Libtayo was reviewed by FDA under Priority Review, a method reserved for medicines representing a potential improvement in efficacy or safety in treatments of
- FDA Approves Cemiplimab as Adjuvant Immunotherapy for High . . .
Last week, Regeneron announced the U S Food and Drug Administration (FDA) approval of cemiplimab-rwlc (Libtayo) as an adjuvant treatment for adult patients with cutaneous squamous cell carcinoma (CSCC), particularly in those with a high risk of recurrence after surgery and radiation 1 The PD-1 inhibitor was evaluated under priority review
- FDA Approves Cemiplimab for Adjuvant Cutaneous Squamous Cell . . .
The US FDA has approved the supplemental biologics license application (sBLA) for cemiplimab-rwlc (Libtayo) as adjuvant treatment in adults with high-risk cutaneous squamous cell carcinoma (CSCC) 1 The sBLA approval was based on an extensive review of data from the pivotal phase 3 C-POST study (NCT03969004) which demonstrated a statistically significant and clinically meaningful improvement
- FDA Approval of Cemiplimab: A New Era for High-Risk CSCC . . .
In a significant step forward for skin cancer management, the U S Food and Drug Administration (FDA) has approved cemiplimab-rwlc (Libtayo) as an adjuvant treatment for adults with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence following surgery and radiation The decision, announced on October 8, 2025, marks the first approval of a PD-1 inhibitor for this specific post
- FDA Approves Cemiplimab as Adjuvant Treatment for Cutaneous . . .
Cemiplimab's approval is supported by findings from the C-POST clinical trial The FDA approved cemiplimab-rwlc (Libtayo; Regeneron Pharmaceuticals) for the adjuvant treatment of adults with cutaneous squamous cell carcinoma (CSCC) who are at a high risk of recurrence following surgery and radiation
- FDA Approves Libtayo for Adjuvant Treatment of High-Risk CSCC
Findings showed cemiplimab reduced the risk of disease recurrence or death by 68% compared with placebo The Food and Drug Administration (FDA) has approved Libtayo ® (cemiplimab-rwlc) for the
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