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- 2025 FDA added indications to dermatologic medications
In October 2025, the FDA approved Libtayo (cemiplimab) as a treatment for cutaneous squamous cell carcinoma that has a high risk of recurring after it has been treated with surgery and radiation
- Behind the FDA Approval: Adjuvant Cemiplimab Shifts Treatment . . .
Vishal A Patel, MD, discusses the FDA approval of cemiplimab in cutaneous squamous cell carcinoma On October 8, 2025, the US FDA approved the immunotherapy cemiplimab-rwlc (Libtayo) for adjuvant treatment of adult patients with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence
- Neoadjuvant and Adjuvant Treatment Approaches Expand Options . . .
Data from C-POST supported the October 2025 FDA approval of cemiplimab for the adjuvant treatment of adult patients with CSCC at a high risk of recurrence after surgery and radiation 3
- Libtayo® (cemiplimab-rwlc) Approved in the U. S. as First
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
- 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 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 to Help Prevent Return of High-Risk Skin . . .
The FDA has approved cemiplimab-rwlc (Libtayo) as a new treatment option to help prevent cutaneous squamous cell carcinoma (CSCC) from returning after surgery and radiation This approval brings hope to adults with CSCC who are at high risk of the cancer coming back, offering another way to lower the chances of recurrence Who Can Benefit? This new approval is intended for patients who have
- Libtayo (cemiplimab-rwlc) - OHSU
Other treatment options including, but are not limited to, the following may be appropriate: radiation therapy, surgery, traditional chemotherapy (e g , platinum, taxane), compassionate use expanded access programs, clinical trials, supportive care, integrative and complementary therapies
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