Basic Information
Libtayo
Regulatory Information
EMEA/H/C/004844
June 28, 2019
April 26, 2019
20
November 4, 2024
Company Information
Ireland
One Warrington Place Dublin 2 D02 HH27
REGENERON IRELAND DESIGNATED ACTIVITY COMPANY
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication 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. 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.
Overview Summary
Libtayo is a cancer medicine used in adults to treat: - a type of skin cancer called cutaneous squamous cell carcinoma when the cancer is locally advanced (has spread nearby) or metastatic (has spread to other parts of the body). It is used in patients who cannot have surgery or treatment with radiation to cure their disease; - a type of skin cancer called basal cell carcinoma (BCC) when the cancer is locally advanced or metastatic. It is used in patients who cannot tolerate treatment with a type of medicine called a ‘hedgehog pathway inhibitor (HHI)’ or whose disease has worsened after such treatment; - a type of lung cancer called non-small cell lung cancer (NSCLC) when the cancer is locally advanced and cannot be treated with chemotherapy (medicines to treat cancer) and radiation therapy, or when the cancer is metastatic. It is used either alone in patients whose tumours have a protein called PD-L1 in more than 50% of cells and no mutations in the genes EGFR,ALK and ROS1 involved in the development of NSCLC, or together with platinum-based chemotherapy in patients whose tumours have PD-L1 in at least 1% of the cells and no mutations in the EGFR,ALK and ROS1 - cervical cancer that has come back (recurrent) or is metastatic. It is used in patients whose disease has progressed during or after treatment with platinum-based chemotherapy. Libtayo contains the active substance cemiplimab.