Libtayo
Authorised
This medicine is authorised for use in the European Union
cemiplimab
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
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.
Treatment with Libtayo must be started and supervised by a doctor experienced in treating cancer. The medicine can only be obtained with a prescription.
Libtayo is given as an infusion (drip) into a vein once every 3 weeks. Treatment can continue for as long as the disease remains stable and the patient does not experience unacceptable side effects.
For more information about using Libtayo, see the package leaflet or contact your doctor or pharmacist.
The active substance in Libtayo, cemiplimab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to a receptor (target) called PD-1 found on certain cells of the immune system called T cells. Cancer cells can make proteins (PD-L1 and PD-L2) that attach to this receptor and switch off the activity of the T cells, preventing them from attacking the cancer. By attaching to the receptor, cemiplimab prevents PD-L1 and PD-L2 from switching off the T cells, thereby increasing the ability of the immune system to kill cancer cells.
Cutaneous squamous cell carcinoma
Libtayo is effective at treating cutaneous squamous cell carcinoma in patients. In a main study involving a total of 193 patients, the cancer shrank in around 39% of patients with metastatic disease who received Libtayo every 3 weeks for around one year. Among patients with locally advanced disease who received Libtayo every 2 weeks for around 2 years, 44% of patients showed shrinkage of their cancer.
Basal cell carcinoma
Treatment with Libtayo showed benefits in patients with locally advanced and metastatic BCC. In a study involving patients who were given Libtayo for around one year, the cancer shrank in 32% (27 out of 84) of patients with locally advanced disease and 29% (10 out of 35) of patients with metastatic disease. Libtayo was not compared with another treatment in this study.
Non-small cell lung cancer
In a study involving 710 patients with advanced or metastatic EGFR/ALK/ROS1-negative NSCLC with high levels of PD-L1 (in more than 50% of tumour cells), patients treated with Libtayo lived longer (about 22 months on average) than those treated with platinum-based chemotherapy (about 14 months). Patients treated with Libtayo lived without their disease getting worse for 6.2 months on average, compared with 5.6 months for patients given chemotherapy.
A second study involving 466 patients with advanced or metastatic EGFR/ALK/ROS1-negative NSCLC found that in patients whose tumours produce PD-L1 in at least 1% of cells, Libtayo given with platinum-based chemotherapy increased the time that patients lived. Of the 327 patients with PD-L1 in at least 1% of tumour cells, those treated with Libtayo plus platinum-based chemotherapy lived for an average of 22 months compared with 13 months for those treated with platinum-based chemotherapy alone. In addition, patients treated with Libtayo plus chemotherapy lived for about 9 months without their disease getting worse, compared with 6 months for patients given chemotherapy alone.
Cervical cancer
In a main study in 608 patients with recurrent or metastatic cervical cancer previously treated with platinum-based chemotherapy, patients given Libtayo lived for about 12 months, compared with 8.5 months for those given chemotherapy. On average, patients treated with Libtayo lived without their disease getting worse for 2.8 months, compared with 2.9 months for patients given chemotherapy.
For the full list of side effects and restrictions with Libtayo, see the package leaflet.
Libtayo is associated with side effects related to the activity of the immune system, which can be serious, although most side effects go away with appropriate treatment or on stopping the medicine.
When Libtayo is used alone, the most common immune-related effects (which may affect up to 1 in 10 people) include hypothyroidism (an underactive thyroid gland with tiredness, weight gain, and skin and hair changes), hyperthyroidism (an overactive thyroid gland which can cause weight loss, nervousness, rapid heartbeat and tiredness), pneumonitis (inflammation in the lungs causing shortness of breath and cough), hepatitis (inflammation of the liver), colitis (inflammation of the large bowel) and skin reactions.
When Libtayo is used with platinum-based chemotherapy, the most common immune-related effects (which may affect up to 1 in 10 people) include hypothyroidism, hyperthyroidism, increased or decreased levels of thyroid-stimulating hormone in the blood (which could be signs of an underactive or overactive thyroid gland), skin reactions and pneumonitis.
Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis (life-threatening reactions with flu-like symptoms and painful rash affecting the skin, mouth, eyes and genitals) have been reported with Libtayo.
Libtayo is effective at treating cutaneous squamous cell carcinoma, a cancer with few treatment options once it has spread, and basal cell carcinoma, for which no other options were available for second-line treatment (treatment given when first treatment is not sufficiently effective or stops working) at the time of authorisation. Libtayo also showed promising effectiveness in the treatment of NSCLC with high PD-L1 levels and in the treatment of cervical cancer after progression during or after treatment with platinum-based chemotherapy. Libtayo used in combination with platinum-based chemotherapy is also effective at treating NSCLC where at least 1% of tumour cells produce PD-L1.
As for the medicine’s safety, Libtayo’s side effects are considered manageable and similar to those seen with other monoclonal antibody cancer treatments.
The European Medicines Agency therefore decided that Libtayo’s benefits are greater than its risks and it can be authorised for use in the EU.
Libtayo was originally given ‘conditional authorisation’ because there was more evidence to come about the medicine. As the company has supplied the additional information necessary, the authorisation has been switched from conditional to full authorisation.
The company that markets Libtayo will provide a guide and an alert card for patients with information on the signs and symptoms of immune-related side effects of the medicine, as well as instructions on contacting their doctor if they experience symptoms.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Libtayo have also been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Libtayo are continuously monitored. Side effects reported with Libtayo are carefully evaluated and any necessary action taken to protect patients.
Libtayo received a conditional marketing authorisation valid throughout the EU on 28 June 2019. This was switched to a standard marketing authorisation on 1 July 2022.
Product information
Latest procedure affecting product information:
N/0049
01/11/2024
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Libtayo
- Active substance
- Cemiplimab
- International non-proprietary name (INN) or common name
- cemiplimab
- Therapeutic area (MeSH)
- Carcinoma, Squamous Cell
- Anatomical therapeutic chemical (ATC) code
- L01XC33
Pharmacotherapeutic group
Antineoplastic agentsTherapeutic 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.
News on Libtayo
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