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: As monotherapy 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

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.

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Medicine details

Medicine name:
cemiplimab (Libtayo)
SMC ID:
SMC2489
Indication:

As monotherapy 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

Pharmaceutical company
Sanofi
BNF chapter
Malignant disease and immunosuppression
Submission type
Non submission
Status
Not recommended
Date advice published
09 May 2022