Cutaneous squamous cell carcinoma

The EU has approved 2 indications of 1 drug in cutaneous squamous cell carcinoma. None of them needs a biomarker result. 6 tumour-agnostic approvals also apply when the tumour carries the alteration.

Disease setting

Approved indications, Cutaneous squamous cell carcinoma
DrugBiomarker requirementRegimenSettingConditions
No biomarker required2
Cemiplimab
Libtayo
None
Monotherapy
Adj.
After surgery and radiation; High risk of recurrence
Cemiplimab
Libtayo
None
Monotherapy
Any line
advanced
Not candidates for curative surgery or curative radiation

Tumour-agnostic approvals6

Approved for any solid tumour that carries the alteration, wherever the tumour started.

DrugBiomarker requirementRegimenSettingConditions
EpCAM1
Monotherapy
2L
Malignant ascites; not eligible for further systemic anticancer therapy
HER21
Trastuzumab deruxtecan
Enhertuconditional
HER2-positive (IHC 3+)
Monotherapy
2L
advanced
After prior treatment; No satisfactory treatment options
NTRK fusion3
Entrectinib
Rozlytrekconditional
Monotherapy
Any line
No prior NTRK inhibitor; Older than 1 month; disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity; no satisfactory treatment options
Larotrectinib
Vitrakviconditional
Monotherapy
Any line
Locally advanced, metastatic or where surgical resection is likely to result in severe morbidity; no satisfactory treatment options
Repotrectinib
Augtyroconditional
Monotherapy
Any line
advanced
Prior NTRK inhibitor, or no prior NTRK inhibitor and treatment options not targeting NTRK provide limited clinical benefit or have been exhausted; Aged 12 years and older
RET fusion1
Monotherapy
Any line
advanced
Treatment options not targeting RET provide limited clinical benefit, or have been exhausted; Aged 2 years and older
Label wording2

The sentence from section 4.1 of the SmPC that each indication above comes from.

  1. Cemiplimab (Libtayo)
    LIBTAYO as monotherapy is indicated for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma (mCSCC or laCSCC) who are not candidates for curative surgery or curative radiation.
  2. Cemiplimab (Libtayo)
    LIBTAYO as monotherapy is indicated for the adjuvant treatment of adult patients with CSCC at high risk of recurrence after surgery and radiation (see section 5.1 for selection criteria).