Cemiplimab

Cemiplimab (Libtayo, Regeneron Ireland Designated Activity Company (DAC)) has 6 EU-approved indications in 4 tumour types. 2 need a biomarker result: PD-L1 (2).
Approved indications of Cemiplimab
Biomarker requirementRegimenSettingConditions
Non-small cell lung cancer2
PD-L1 TPS ≥ 1%, EGFR/ALK/ROS1-negative
+ platinum-based chemotherapy
1L
advanced
Locally advanced patients must not be candidates for definitive chemoradiation
PD-L1 TPS ≥ 50%, EGFR/ALK/ROS1-negative
Monotherapy
1L
advanced
Locally advanced patients must not be candidates for definitive chemoradiation
Cervical cancer1
None
Monotherapy
2L
advanced
After platinum-based chemotherapy
Cutaneous squamous cell carcinoma2
None
Monotherapy
Adj.
After surgery and radiation; High risk of recurrence
None
Monotherapy
Any line
advanced
Not candidates for curative surgery or curative radiation
Basal cell carcinoma1
None
Monotherapy
2L
advanced
Progressed on or intolerant to a hedgehog pathway inhibitor (HHI)
Full text of section 4.1 (therapeutic indications)

Cutaneous Squamous Cell Carcinoma 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. 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). Basal Cell Carcinoma LIBTAYO as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic basal cell carcinoma (laBCC or mBCC) who have progressed on or are intolerant to a hedgehog pathway inhibitor (HHI). Non-Small Cell Lung Cancer LIBTAYO as monotherapy is indicated for the first-line treatment of adult patients with non-small cell lung cancer (NSCLC) expressing PD-L1 (in ≥ 50% tumour cells), with no EGFR, ALK or ROS1 aberrations, who have: • locally advanced NSCLC who are not candidates for definitive chemoradiation, or • metastatic NSCLC. LIBTAYO in combination with platinum-based chemotherapy is indicated for the first‐line treatment of adult patients with NSCLC expressing PD-L1 (in ≥ 1% of tumour cells), with no EGFR, ALK or ROS1 aberrations, who have: • locally advanced NSCLC who are not candidates for definitive chemoradiation, or • metastatic NSCLC. Cervical Cancer LIBTAYO as monotherapy is indicated for the treatment of adult patients with recurrent or metastatic cervical cancer and disease progression on or after platinum-based chemotherapy.

Label history

27 changes to the Libtayo label since 2020, 5 of them to the indications. Newest first, in the words of EMA's record of each procedure.

Changes