What Is Cemiplimab (Libtayo)? FDA Approval, Licensing in Turkey, and Reimbursement
| Active ingredient | Cemiplimab (cemiplimab-rwlc) |
| Brand name | Libtayo |
| Class | PD-1 inhibitor (immune checkpoint inhibitor) |
| Category | Immunotherapy (fully human IgG4 monoclonal antibody) |
| Route of administration | Intravenous infusion (approximately 30 minutes) |
| Dosing frequency | 350 mg every 3 weeks (for some indications, a maintenance option of 700 mg every 6 weeks is also approved) |
| FDA-approved cancer indications | Advanced cutaneous squamous cell carcinoma (CSCC, 2018; adjuvant CSCC, 2025), basal cell carcinoma (BCC, 2021), NSCLC (NSCLC — monotherapy and combination with platinum-based chemotherapy, 2021/2022) |
| Additional EU-approved indication | Recurrent/metastatic cervical cancer (European Commission, November 2022) — this indication is not approved by the FDA; the application was withdrawn in 2022 |
| FDA-approved | Yes (initial approval: September 28, 2018) |
| Manufacturer | Regeneron Pharmaceuticals (jointly developed with Sanofi until 2022; global rights have been held entirely by Regeneron since 2022) |
| Turkish Ministry of Health license | NONE — cemiplimab is not yet licensed in Turkey |
| SGK reimbursement | NONE — because it is unlicensed, it is not included in the List of Reimbursable Medicines |
| Access in Turkey | Individual/institutional supply under the TİTCK Overseas Medicines List, with a physician's report and through the TEB (Turkish Pharmacists' Association) Pharmaceutical Warehouse |
| Approximate cost | According to overseas list prices and exchange rates, the cost varies — see the "Price" section below |
| Elimination half-life | Approximately 19-20 days (typical pharmacokinetics of a large IgG4 monoclonal antibody) |
Cemiplimab (Libtayo)is a fully human monoclonal PD-1 inhibitor that blocks PD-1 on immune cells, restoring the ability of T cells to recognize and destroy cancer cells. Since its initial approval (2018), its range of indications has expanded from skin cancers to lung cancer; its latest FDA approval was granted in 2025 for adjuvant (postoperative) CSCC treatment.
This monograph covers its mechanism, FDA approval history, key clinical trial data from the EMPOWER series, dosing and administration, safety profile, and current licensing and SGK status in Turkey, together with a realistic cost framework . This article is a corrected version of an earlier publication that contained some outdated statements about prices and indications.
On T cells, the PD-1 receptor is normally a control mechanism that prevents the immune system from damaging healthy tissue. Cancer cells exploit this brake by producing ligands such as PD-L1, suppressing T cells and evading the immune system.
Cemiplimab binds to the PD-1 receptor and prevents this suppression. This reactivates T cells, allowing them to sustain an immune response against tumor cells. Its mechanism is broadly similar to that of other PD-1 inhibitors in the same class, such as pembrolizumab and nivolumab.
- The entry "August 3, 2022: Antitumor activity in prostate cancer" does not represent an approval and was misleading when included in an approval history; it has been removed.
- Approval for cervical cancer applies only in Europe (EMA/European Commission). In the US, the FDA reported in 2022 that the application (sBLA) for this indication had been withdrawn ; cemiplimab is not FDA-approved for this indication. The earlier version did not make this distinction.
- Adjuvant CSCC approval (October 8, 2025) was entirely absent from the previous version; it has been added as one of the latest important approvals.
| Date | Approval | Supporting trial |
|---|---|---|
| September 28, 2018 | Metastatic or locally advanced CSCC not amenable to surgery/radiotherapy — initial FDA approval, the first medicine approved for advanced CSCC | EMPOWER-CSCC-1 |
| February 9, 2021 | Locally advanced/metastatic basal cell carcinoma (BCC) that has not responded to a Hedgehog pathway inhibitor (HHI), or in patients for whom an HHI is inappropriate | Phase 2 trial |
| February 22, 2021 | First-line monotherapy for advanced NSCLC with PD-L1 expression ≥50% and no EGFR/ALK/ROS1 alterations | EMPOWER-Lung 1 |
| November 8, 2022 | Combination with platinum-based chemotherapy for advanced NSCLC without EGFR/ALK/ROS1 alterations (first-line) | EMPOWER-Lung 3 |
| October 14, 2022 / November 22, 2022 | (EU only) Positive CHMP opinion followed by European Commission approval: Recurrent/metastatic cervical cancer after platinum treatment | EMPOWER-Cervical 1 |
| October 8, 2025 | For patients with CSCC at high risk of recurrence after surgery and radiotherapy, adjuvant treatment — one of the latest approvals | C-POST (Phase 3, n=415) |
In EMPOWER-Cervical 1, compared with investigator's choice of chemotherapy in the overall population, cemiplimab reduced the risk of death by 31% (HR 0.69). This is one of the strongest survival signals demonstrated by PD-1 inhibitors in cervical cancer, but these data did not lead to FDA approval; Regeneron/Sanofi withdrew the application after failing to reach agreement with the FDA on postmarketing study requirements.
| Trial | Indication | Key finding |
|---|---|---|
| EMPOWER-CSCC-1 | Advanced CSCC | Objective response rates of approximately 40-50% have been reported; it became the first approved systemic treatment for this disease. |
| EMPOWER-Lung 1 | PD-L1 ≥50% NSCLC, monotherapy | A significant improvement in overall survival versus chemotherapy was demonstrated. |
| EMPOWER-Lung 3 | NSCLC, combination with chemotherapy | A survival advantage was demonstrated in the combination arm regardless of PD-L1 status. |
| EMPOWER-Cervical 1 | Recurrent/metastatic cervical cancer | A 31% reduction in the risk of death (HR 0.69); resulted in approval only in the EU. |
| C-POST | Adjuvant CSCC (n=415) | Disease-free survival benefit in patients at high risk of recurrence after surgery/radiotherapy; the basis for the 2025 FDA approval. |
350 mg every 3 weeks, by intravenous infusion over approximately 30 minutes . For some indications, after the first few doses, an alternative maintenance regimen of 700 mg every 6 weeks is also included in the approved prescribing information. The treating oncologist decides which regimen to use. Treatment continues until disease progression or intolerable toxicity.
- As with all PD-1/PD-L1 inhibitors, cemiplimab may cause pneumonitis, hepatitis, thyroiditis, colitis, and skin reactions that are immune-mediated.
- Regular laboratory monitoring of liver enzymes, thyroid function, and renal function is recommended throughout treatment.
- Graft rejection has been reported in patients with a history of organ transplantation; use during pregnancy is not recommended because of the risk of fetal harm.
The most frequently reported adverse effects in clinical trials include fatigue, rash, musculoskeletal pain, diarrhea, and loss of appetite . Exact frequencies vary by indication and combination regimen, including monotherapy versus use with chemotherapy. For current indication-specific rates, consult the FDA-approved Prescribing Information.
Licensing status: As of the date this article was prepared, cemiplimab (Libtayo) has not been licensed by the Turkish Ministry of Health / TİTCK. It cannot be obtained from a pharmacy in Turkey on prescription.
Access: For medicines that are unlicensed in Turkey but approved abroad, individual or institutional supply is possible through the TİTCK Overseas Medicine Supply mechanism, with a physician's report and through the TEB Pharmaceutical Warehouse.
Reimbursement: Because it is unlicensed, it is not included in the SGK List of Reimbursable Medicines. The patient bears the cost unless a court order or an exceptional SGK decision provides otherwise.
The final cost of individually or institutionally imported medicines varies according to the reference country's list price, local VAT and discounts, the importing TEB warehouse's service fee, logistics costs, and the exchange rate at the time . Giving a single "definitive price in Turkish lira" would therefore be misleading.
To provide a rough indication: The reported list price for the public health system in the UK (NICE) per 350 mg vial was approximately £4,650 (excluding VAT, 2022 data); the US launch list price (WAC) per 3-week cycle was announced as approximately 9,100 US dollars . These figures have changed over time and do not directly reflect the final import cost in Turkey. For a current, exact price, an updated quotation should be obtained from the relevant TEB Pharmaceutical Warehouse or the hospital/oncology center planning treatment.
- Confirm with your oncologist that the indication is appropriate. Cemiplimab is approved only for certain cancers and disease stages; it is not a medicine that can be used for "every cancer."
- Remember that it is unlicensed in Turkey. Access is possible through the TİTCK overseas medicine supply procedure, with a physician's report.
- Ask for an updated written price quotation. Because the cost depends on exchange rates, obtaining a current written quotation from the relevant TEB Pharmaceutical Warehouse or hospital pharmacy before treatment is important to avoid surprises.
- Ask about SGK/private insurance coverage in advance. As an unlicensed medicine, it has no standard SGK reimbursement. In some cases, payment may be sought through the courts; consulting the social services unit or a patient rights adviser may be helpful.
As one of the first PD-1 inhibitors approved for skin cancers (CSCC, BCC), cemiplimab changed the standard of care in this field. The 2025 adjuvant CSCC approval is an important development showing that immunotherapy may play a role not only in metastatic disease but also in preventing recurrence .
FDA approvals in CSCC, BCC, and NSCLC, as monotherapy or in combination, are supported by robust clinical data. In cervical cancer, EMPOWER-Cervical 1 showed a strong signal with a 31% reduction in the risk of death, but this led to approval only in Europe. The 2025 adjuvant CSCC approval, based on C-POST, demonstrated a significant improvement in disease-free survival.
The cervical cancer indication is not FDA-approved ; overlooking this distinction may create unrealistic expectations for patients. In Turkey, there is no license or SGK reimbursement; access is possible only through overseas medicine supply at the patient's own expense. Prices fluctuate with exchange rates, making a single fixed Turkish lira price misleading.
To avoid creating expectations outside the approved indications, patients should be told clearly which cancers and stages are covered by approval. For patients planning treatment in Turkey, managing the overseas medicine supply process from the outset, including the physician's report, TEB warehouse, and updated quotation, reduces treatment delays and unexpected costs.
Will a new FDA application be pursued for the cervical cancer indication? Will the adjuvant CSCC approval affect licensing in Turkey? More broadly, when will a Turkish marketing authorization application for cemiplimab be submitted? This will be a key development for accessibility and cost.
- U.S. FDA. Libtayo (cemiplimab-rwlc) Approval History. Drugs.com / FDA.gov, latest access 2026.
- FDA approves cemiplimab-rwlc for adjuvant treatment of cutaneous squamous cell carcinoma. FDA.gov, October 8, 2025 (C-POST trial, NCT03969004).
- European Commission Approves Cemiplimab for Recurrent/Metastatic Cervical Cancer. CancerNetwork, November 2022 (EMPOWER-Cervical 1, NCT03257267).
- Cemiplimab Biologics License Application for Advanced Cervical Cancer Withdrawn Following Discourse With FDA. CancerNetwork, 2022.
- Tewari KS, Monk BJ, Vergote I, et al. Survival with cemiplimab in recurrent cervical cancer. N Engl J Med. 2022;386(6):544-555.
- SEER Cancer.gov — Cemiplimab drug information and approval remarks.
- NICE. Cemiplimab for treating advanced cutaneous squamous cell carcinoma (TA802) — list price data.
- ClinicalTrials.gov: NCT03257267 (EMPOWER-Cervical 1), NCT03969004 (C-POST), EMPOWER-Lung 1/3, EMPOWER-CSCC-1.
- TİTCK — Guideline on Overseas Medicine Supply and lists of licensed medicines (titck.gov.tr).
- Current EUR/TRY exchange rate data, July 2026 (ECB, various foreign exchange platforms).
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