Approved as a first- or later-line therapy for a broad range of patients with advanced cutaneous squamous cell
Characteristics of patients with metastatic CSCC or locally advanced CSCC who were not candidates for curative surgery or curative radiation who were enrolled in Studies 1423 and 1540
(N = 108)
|Metastatic CSCC, n
|Locally advanced CSCC, n
|Median age, years (range)
|ECOG Performance Status, %
Additional characteristics of enrolled patients with metastatic CSCC or locally advanced CSCC who were not candidates for curative surgery or curative radiation
of patients received LIBTAYO as first-line systemic therapy
of patients had received prior cancer-related surgery
of patients had received any prior radiotherapy
of metastatic patients had distant metastasis
of metastatic patients had only nodal metastasis
Programmed death ligand 1 (PD-L1) testing is not
required before starting LIBTAYO.
LIBTAYO is approved for a wide variety of patients with advanced CSCC1
Candidates for LIBTAYO
Locally advanced CSCC1
- Locally advanced CSCC patients who are not candidates for curative surgery or curative
Situations when surgery or radiation may not be appropriate2-4,a
- Locally invasive: tumor extending into underlying tissue, cartilage, bone, or nerve
- Nodal involvement due to direct invasion from overlying skin
- Perineural involvement due to direct extension that is apparent on imaging
- In-transit metastasis of the skin (without evidence of nodal, parotid, or distant disease)
Location of disease
- Periorbital lesions threatening the eye
- Nasal or auricular lesion requiring rhinectomy or auriculectomy
- CSCC lesions of head and neck area with direct extension into sinuses
Expected deformity or morbidity
- Anticipation of substantial morbidity or deformity from surgery
- Recurrence of CSCC at the same site after 2 or more surgical procedures
- Deep recurrence underlying site of previously resected cutaneous lesion (if no nodal or metastatic involvement)
- Patient refusal of surgery
- Other conditions deemed to be contraindicating for surgery
Location of disease
- Anatomically challenging locations for which radiation therapy (RT) would be associated with unacceptable toxicity
- Further RT would exceed the threshold of acceptable cumulative dose
- Patient refusal of RT
- Clinical judgment that tumor is unlikely to respond to RT
- Other conditions deemed to be contraindicating for RT
Indication and Usage
LIBTAYO is indicated for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation.
- LIBTAYO (cemiplimab-rwlc) injection full U.S. prescribing information. Regeneron Pharmaceuticals, Inc., and sanofi-aventis U.S. LLC.
- Data on file. Regeneron Pharmaceuticals Inc.
- Alam M et al. J Am Acad Dermatol. 2018;78(3):560-578.
- Migden MR et al. N Engl J Med. 2018;379(4):341-351.