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SMC ID Date Medicine Submission Type Indication
SMC2719 10/02/2025 cemiplimab (Libtayo) Full

As monotherapy for the treatment of adult patients with recurrent or metastatic cervical cancer and disease progression on or after platinum-based chemotherapy.

SMC2724 07/10/2024 cemiplimab (Libtayo) Non submission

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

SMC2584 11/12/2023 cemiplimab (Libtayo) Reassessment

As monotherapy for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) who are not candidates for curative surgery or curative radiation.

SMC2489 09/05/2022 cemiplimab (Libtayo) Non submission

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

Publication due date SMC meeting date Medicine Submission Type Indication
TBC TBC cemiplimab (Libtayo) Full

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
TBC TBC cemiplimab (Libtayo) Full

In combination with platinum‐based chemotherapy 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