Advice

In the absence of a submission from the holder of the marketing authorisation:

cemiplimab (Libtayo®) is not recommended for use within NHSScotland.

Indication under review: in combination with platinum‐based chemotherapy for the first‐line treatment of adult patients with non-small cell lung cancer (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.

The holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication. As a result, we cannot recommend its use within NHSScotland.

The holder of the marketing authorisation has indicated that they plan to make a submission to SMC in the future.

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Medicine details

Medicine name:
cemiplimab (Libtayo)
SMC ID:
SMC2724
Indication:

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

Pharmaceutical company
Regeneron Pharmaceuticals Inc
BNF chapter
Malignant disease and immunosuppression
Submission type
Non submission
Status
Not recommended
Date advice published
07 October 2024