Libtayo
Opinion
On 23 February 2023, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Libtayo. The marketing authorisation holder for this medicinal product is Regeneron Ireland Designated Activity Company (DAC).
The CHMP adopted a new indication as follows:
Non-Small Cell Lung Cancer (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.
For information, the full indications for Libtayo will be as follows1:
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.
Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.
1 New text in bold
Key facts
Name |
Libtayo |
Agency product number |
EMEA/H/C/004844 |
International non-proprietary name (INN) or common name |
|
Active substance |
|
Therapeutic area |
Carcinoma, Squamous Cell
|
Additional monitoring |
This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring. |
Conditional approval |
This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation. |
Date opinion adopted |
23/02/2023 |
Company name | |
Status |
Positive |
Application type |
Post-authorisation |
News
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24/02/2023
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 October 202214/10/2022
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21/05/2021
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26/04/2019