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FDA approves cemiplimab-rwlc for adjuvant treatment of cutaneous ...
On October 8, 2025, the Food and Drug Administration approved cemiplimab-rwlc (Libtayo, Regeneron Pharmaceuticals Inc.) for the adjuvant treatment of adults with cutaneous squamous cell carcinoma ...

LIBTAYO® (cemiplimab-rwlc) | Official HCP Website
LIBTAYO® (cemiplimab-rwlc) is a prescription medicine indicated for the treatment of adult patients with advanced NSCLC, CSCC, BCC, and as an adjuvant treatment for high-risk CSCC. See Important Safety & full Prescribing Information.

Libtayo® (cemiplimab-rwlc) Approved in the U.S. as First and ... - KTLA
The FDA evaluated Libtayo under Priority Review, which is reserved for medicines that represent potentially significant improvements in efficacy or safety in the treatment of serious conditions.

Libtayo (cemiplimab-rwlc) Approved in the U.S. as First and Only ...
FDA approves Libtayo (cemiplimab-rwlc) as adjuvant treatment for adults with high-risk cutaneous squamous cell carcinoma after surgery and radiation.

Covering Every FDA Oncology Approval From October 2025
FDA Approves Libtayo for High-Risk Cutaneous Squamous Cell Carcinoma The FDA has approved Libtayo (cemiplimab-rwlc) for adjuvant treatment in adults with cutaneous squamous cell carcinoma at high risk of recurrence after surgery and radiation. This approval was based on the C-POST trial, which included 415 patients at high risk of recurrence.

FDA Approves Cemiplimab for Adjuvant Cutaneous Squamous Cell Carcinoma
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 OK’s cemiplimab as adjuvant treatment for skin cancer
The FDA has approved cemiplimab-rwlc for adjuvant treatment of adults with cutaneous squamous cell carcinoma at high risk for recurrence after surgery and radiation.Cemiplimab-rwlc (Libtayo ...

FDA Approval of Cemiplimab: A New Era for High-Risk CSCC Treatment
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 Libtayo for high-risk CSCC after surgery and radiation
This new approval extends its use to an earlier treatment setting, potentially changing the treatment paradigm for high-risk patients following surgery and radiation.

Cemiplimab-rwlc (Libtayo) Updates 2025: Uses in cancer, Side effects ...
Cemiplimab, marketed as Libtayo, has received multiple FDA approvals for the treatment of advanced cancers. Its approvals span both skin and lung cancers, offering new therapeutic options for patients with limited alternatives.

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